NDC Code(s) : 49349-815-02
Packager : REMEDYREPACK 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:49349-815
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
AMMONIA(UNII: 5138Q19F1X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
OLEIC ACID(UNII: 2UMI9U37CP)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C RED NO. 28(UNII: 767IP0Y5NH)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
Color purple, pink Score no score
Shape CAPSULE (CAPSULE, EXTENDED RELEASE) Size 15 mm
Flavor Imprint Code MYLAN;5280
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-815-0230 in 1 BLISTER PACK Type 0: Not a Combination Product14/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075124 11/14/2011 10/31/2013

PRINCIPAL DISPLAY PANEL

DRUG: Diltiazem Hydrochloride

GENERIC: Diltiazem Hydrochloride

DOSAGE: CAPSULE, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 49349-815-02

STRENGTH:180 mg

COLOR: purple

SHAPE: CAPSULE

SCORE: No score

SIZE: 15 mm

IMPRINT: 30

QTY: 30

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