NDC Code(s) : 61786-370-23
Packager : REMEDYREPACK INC.

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:61786-370(NDC:0378-6090)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DILTIAZEM HYDROCHLORIDE(UNII: OLH94387TE)
(DILTIAZEM - UNII:EE92BBP03H) 		DILTIAZEM HYDROCHLORIDE90 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIETHYL PHTHALATE(UNII: UF064M00AF)
HYPROMELLOSES(UNII: 3NXW29V3WO)
GELATIN(UNII: 2G86QN327L)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)(UNII: 5KY68S2577)
POVIDONES(UNII: FZ989GH94E)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color PINK (Coral opaque), WHITE (White opaque) Score no score
Shape CAPSULE (CAPSULE, EXTENDED RELEASE) Size 14 mm
Flavor Imprint Code MYLAN;6090
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-370-23180 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074910 07/16/2015

PRINCIPAL DISPLAY PANEL

DRUG: Diltiazem Hydrochloride


GENERIC: diltiazem hydrochloride


DOSAGE: CAPSULE, EXTENDED RELEASE


ADMINSTRATION: ORAL


NDC: 61786-370-23


ACTIVE INGREDIENT(S):

  • DILTIAZEM HYDROCHLORIDE 90mg in 1


INACTIVE INGREDIENT(S):

  • D&C YELLOW NO. 10
  • FERROSOFERRIC OXIDE
  • SODIUM LAURYL SULFATE
  • TITANIUM DIOXIDE
  • FD&C BLUE NO. 1
  • FD&C BLUE NO. 2
  • FD&C RED NO. 40
  • SILICON DIOXIDE
  • DIETHYL PHTHALATE
  • HYPROMELLOSES
  • GELATIN
  • MALTODEXTRIN
  • METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)
  • POVIDONES
  • POLYETHYLENE GLYCOLS
  • PROPYLENE GLYCOL


COLOR: pink


SHAPE: CAPSULE


SCORE: No score


SIZE: 14 mm


IMPRINT: MYLAN;6090


PACKAGING: 180 in 1 BOTTLE, PLASTIC




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