NDC Code 0781-2452-92 - Diltiazem Hydrochloride

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)	DILTIAZEM HYDROCHLORIDE	120 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0781-2452-31	30 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
2	NDC:0781-2452-92	90 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
3	NDC:0781-2452-05	500 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)	DILTIAZEM HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0781-2453-31	30 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
2	NDC:0781-2453-92	90 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
3	NDC:0781-2453-05	500 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)	DILTIAZEM HYDROCHLORIDE	240 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0781-2454-31	30 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
2	NDC:0781-2454-92	90 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
3	NDC:0781-2454-05	500 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)	DILTIAZEM HYDROCHLORIDE	300 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0781-2455-31	30 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
2	NDC:0781-2455-92	90 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
3	NDC:0781-2455-05	500 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)	DILTIAZEM HYDROCHLORIDE	360 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0781-2456-31	30 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
2	NDC:0781-2456-92	90 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
3	NDC:0781-2456-05	500 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)	DILTIAZEM HYDROCHLORIDE	420 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0781-2457-31	30 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
2	NDC:0781-2457-92	90 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012
3	NDC:0781-2457-05	500 in 1 BOTTLE Type 0: Not a Combination Product	01/10/2012