NDC Code(s) : 0781-2452-31, 0781-2452-92, 0781-2452-05, 0781-2453-31, 0781-2453-92, 0781-2453-05, 0781-2454-31, 0781-2454-92, 0781-2454-05, 0781-2455-31, 0781-2455-92, 0781-2455-05, 0781-2456-31, 0781-2456-92, 0781-2456-05, 0781-2457-31, 0781-2457-92, 0781-2457-05
Packager : Sandoz Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-2452
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H) 		DILTIAZEM HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color WHITE, GRAY Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code 1112
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-2452-3130 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
2NDC:0781-2452-9290 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
3NDC:0781-2452-05500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091022 10/01/2012 05/31/2018
Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-2453
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H) 		DILTIAZEM HYDROCHLORIDE180 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 1113
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-2453-3130 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
2NDC:0781-2453-9290 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
3NDC:0781-2453-05500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091022 10/01/2012 05/31/2018
Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-2454
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H) 		DILTIAZEM HYDROCHLORIDE240 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color WHITE, BLUE Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 1114
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-2454-3130 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
2NDC:0781-2454-9290 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
3NDC:0781-2454-05500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091022 10/01/2012 05/31/2018
Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-2455
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H) 		DILTIAZEM HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code 1115
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-2455-3130 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
2NDC:0781-2455-9290 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
3NDC:0781-2455-05500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091022 10/01/2012 05/31/2018
Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-2456
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H) 		DILTIAZEM HYDROCHLORIDE360 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color GRAY, BLUE Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code 1116
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-2456-3130 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
2NDC:0781-2456-9290 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
3NDC:0781-2456-05500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091022 10/01/2012 05/31/2018
Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-2457
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H) 		DILTIAZEM HYDROCHLORIDE420 mg
Inactive Ingredients
Ingredient Name Strength
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color GRAY Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code 1117
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0781-2457-3130 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
2NDC:0781-2457-9290 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
3NDC:0781-2457-05500 in 1 BOTTLE Type 0: Not a Combination Product01/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091022 10/01/2012 05/31/2018

PRINCIPAL DISPLAY PANEL

NDC 0781-2452-31

Diltiazem

Hydrochloride

Extended-Release

Capsules, USP*

120 mg

(Once-a-Day

Dosage)

Rx only

30 Capsules

SANDOZ

Diltiazem Hydrochloride 120 mg Label

PRINCIPAL DISPLAY PANEL

NDC 0781-2453-31

Diltiazem

Hydrochloride

Extended-Release

Capsules, USP*

180 mg

(Once-a-Day

Dosage)

Rx only

30 Capsules

SANDOZ

Diltiazem Hydrochloride 180 mg Label

PRINCIPAL DISPLAY PANEL

NDC 0781-2454-31

Diltiazem

Hydrochloride

Extended-Release

Capsules, USP*

240 mg

(Once-a-Day

Dosage)

Rx only

30 Capsules

SANDOZ

Diltiazem Hydrochloride 240 mg Label

PRINCIPAL DISPLAY PANEL

NDC 0781-2455-31

Diltiazem

Hydrochloride

Extended-Release

Capsules, USP*

300 mg

(Once-a-Day

Dosage)

Rx only

30 Capsules

SANDOZ

Diltiazem Hydrochloride 300 mg Label

PRINCIPAL DISPLAY PANEL

NDC 0781-2456-31

Diltiazem

Hydrochloride

Extended-Release

Capsules, USP*

360 mg

(Once-a-Day

Dosage)

Rx only

30 Capsules

SANDOZ

Diltiazem Hydrochloride 360 mg Label

PRINCIPAL DISPLAY PANEL

NDC 0781-2457-31

Diltiazem

Hydrochloride

Extended-Release

Capsules, USP*

420 mg

(Once-a-Day

Dosage)

Rx only

30 Capsules

SANDOZ

Diltiazem Hydrochloride 420 mg Label