NDC Code(s) : 49349-557-20
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Diltiazem HydrochlorideDiltiazem Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-557(NDC:0093-0318)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H) 		DILTIAZEM HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE K90(UNII: RDH86HJV5Z)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALUMINUM OXIDE(UNII: LMI26O6933)
Product Characteristics
Color orange (faint orange) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 93;318
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-557-20100 in 1 CANISTER Type 0: Not a Combination Product03/10/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074185 10/03/2011 10/03/2012

PRINCIPAL DISPLAY PANEL

DRUG: Diltiazem Hydrochloride

GENERIC: Diltiazem Hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 49349-557-20

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: 93;318

PACKAGING: 100 in 1 CANISTER

ACTIVE INGREDIENT(S):

  • DILTIAZEM HYDROCHLORIDE 30mg in 1

INACTIVE INGREDIENT(S):

  • ALUMINUM OXIDE
  • TITANIUM DIOXIDE
  • FD&C YELLOW NO. 6
  • POVIDONE K90
  • HYPROMELLOSES
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOLS
  • POLYSORBATE 80

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