NDC Code(s) : 24236-040-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Chlordiazepoxide HydrochlorideChlordiazepoxide Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24236-040(NDC:0555-0159)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORDIAZEPOXIDE HYDROCHLORIDE(UNII: MFM6K1XWDK)
(CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR) 		CHLORDIAZEPOXIDE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYDROGENATED COTTONSEED OIL(UNII: Z82Y2C65EA)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
FD&C RED NO. 40(UNII: WZB9127XOA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color green (aqua green), white Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24236-040-0230 in 1 BLISTER PACK Type 0: Not a Combination Product29/08/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084769 08/29/2007 11/17/2016

PRINCIPAL DISPLAY PANEL

DRUG: Chlordiazepoxide Hydrochloride

GENERIC: Chlordiazepoxide Hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 24236-040-02

COLOR: green

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: barr;159

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CHLORDIAZEPOXIDE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • FD&C BLUE NO. 2
  • INDIGOTINDISULFONATE SODIUM
  • FD&C RED NO. 40
  • PROPYLENE GLYCOL
  • TITANIUM DIOXIDE
  • FERROSOFERRIC OXIDE
  • D&C YELLOW NO. 10
  • FD&C BLUE NO. 1
  • GELATIN, UNSPECIFIED
  • HYDROGENATED COTTONSEED OIL
  • MICROCRYSTALLINE CELLULOSE
  • SHELLAC

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