NDC Code(s) : 55154-6836-0
Packager : Cardinal Health

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:55154-6836(NDC:63739-283)
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, UNSPECIFIED(UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (1200000 MW)(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 R;2588
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-6836-010 in 1 BAG 24/07/2007
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074984 07/24/2007 10/31/2018

PRINCIPAL DISPLAY PANEL

Diltiazem Hydrochloride

Extended-Release Capsules, USP

120 mg

[Once-a-Day Dosage]

10 Capsules

bag label