NDC Code(s) : 63739-283-31, 63739-284-31, 63739-285-31
Packager : McKesson Packaging Services Business Unit of McKesson Corporation

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:63739-283(NDC:0228-2588)
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
gelatin(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
propylene glycol(UNII: 6DC9Q167V3)
silicon dioxide(UNII: ETJ7Z6XBU4)
sodium lauryl sulfate(UNII: 368GB5141J)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
triethyl citrate(UNII: 8Z96QXD6UM)
Product Characteristics
Color gray (light gray opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code R2588
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63739-283-311 in 1 DOSE PACK
130 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074984 05/24/2010
Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-284(NDC:0228-2577)
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
AMMONIA(UNII: 5138Q19F1X)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
gelatin(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
propylene glycol(UNII: 6DC9Q167V3)
silicon dioxide(UNII: ETJ7Z6XBU4)
sodium lauryl sulfate(UNII: 368GB5141J)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
triethyl citrate(UNII: 8Z96QXD6UM)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
Product Characteristics
Color blue (aqua blue opaque), green (dark green opaque) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code R2577
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63739-284-311 in 1 DOSE PACK
130 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074984 05/24/2010
Diltiazem HydrochlorideDiltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-285(NDC:0228-2578)
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
AMMONIA(UNII: 5138Q19F1X)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
gelatin(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
propylene glycol(UNII: 6DC9Q167V3)
silicon dioxide(UNII: ETJ7Z6XBU4)
sodium lauryl sulfate(UNII: 368GB5141J)
talc(UNII: 7SEV7J4R1U)
titanium dioxide(UNII: 15FIX9V2JP)
triethyl citrate(UNII: 8Z96QXD6UM)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
Product Characteristics
Color green (dark green opaque) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code R2578
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63739-285-311 in 1 DOSE PACK
130 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074984 05/24/2010

PRINCIPAL DISPLAY PANEL

Diltiazem 120mg label

EACH CAPSULE CONTAINS:
DiltiazemHydrochloride, USP ............120mg

USUAL DOSAGE: Read package outsert for full prescribing information.

Store at controlled room temperature 15° - 30°C (59° - 86°F).

Avoid excessive humidity.

Use immediately upon opening individual capsule blister.

WARNING: Keep out of reach of children.

Only take Diltiazem CD as prescribed by your healthcare professional.

U.S. Patient No. 6,033,687

LS-283-31-M13-01-B

Manufactured by: Actavis Elizabeth LLC
200 Elmora Avenue, Elizabeth, NJ 07207 USA

Distributed by: McKesson Packaging Services a business unit of McKesson Corporation
7101 Weddington Road, Concord, NC 28027

PRINCIPAL DISPLAY PANEL

Diltiazem 180mg Label

EACH CAPSULE CONTAINS:
DiltiazemHydrochloride, USP ............180mg

USUAL DOSAGE: Read package outsert for full prescribing information.

Store at controlled room temperature 15° - 30°C (59° - 86°F).

Avoid excessive humidity.

Use immediately upon opening individual capsule blister.

WARNING: Keep out of reach of children.

Only take Diltiazem CD as prescribed by your healthcare professional.

U.S. Patient No. 6,033,687

LS-284-31-M13-01-B

Manufactured by: Actavis Elizabeth LLC
200 Elmora Avenue, Elizabeth, NJ 07207 USA

Distributed by: McKesson Packaging Services a business unit of McKesson Corporation
7101 Weddington Road, Concord, NC 28027

PRINCIPAL DISPLAY PANEL

Diltiazem 240mg Label

EACH CAPSULE CONTAINS:
DiltiazemHydrochloride, USP ............240mg

USUAL DOSAGE: Read package outsert for full prescribing information.

Store at controlled room temperature 15° - 30°C (59° - 86°F).

Avoid excessive humidity.

Use immediately upon opening individual capsule blister.

WARNING: Keep out of reach of children.

Only take Diltiazem CD as prescribed by your healthcare professional.

U.S. Patient No. 6,033,687

LS-285-31-M13-01-B

Manufactured by: Actavis Elizabeth LLC
200 Elmora Avenue, Elizabeth, NJ 07207 USA

Distributed by: McKesson Packaging Services a business unit of McKesson Corporation
7101 Weddington Road, Concord, NC 28027