NDC Code(s) : 50090-0670-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diltiazem Hydrochloride Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0670(NDC:47335-676)
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
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
TALC(UNII: 7SEV7J4R1U)
ETHYLCELLULOSE (20 MPA.S)(UNII: BJG0S321QY)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
MAGNESIUM STEARATE(UNII: 70097M6I30)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color BLUE, TURQUOISE (light turquoise blue) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code 676;676
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0670-0 30 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090492 10/31/2011

PRINCIPAL DISPLAY PANEL

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