NDC Code(s) : 71335-0338-2, 71335-0338-1
Packager : Bryant Ranch Prepack

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:71335-0338(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, UNSPECIFIED(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL, UNSPECIFIED(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:71335-0338-228 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
2NDC:71335-0338-130 in 1 BOTTLE Type 0: Not a Combination Product24/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091022 10/01/2012

PRINCIPAL DISPLAY PANEL

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