NDC Code(s) : 70518-1752-0, 70518-1752-1
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:70518-1752(NDC:0555-0033)
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 HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLENE GLYCOL MONOETHYL ETHER(UNII: IDK7C2HS09)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM(UNII: 9NEZ333N27)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM PROPIONATE(UNII: DK6Y9P42IN)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYDROGENATED COTTONSEED OIL(UNII: Z82Y2C65EA)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
EDETATE CALCIUM DISODIUM(UNII: 25IH6R4SGF)
Product Characteristics
Color black, green Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code barr;033
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70518-1752-030 in 1 BLISTER PACK Type 0: Not a Combination Product27/12/2018
2NDC:70518-1752-130 in 1 BLISTER PACK Type 0: Not a Combination Product12/10/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083116 12/27/2018

LABELER - REMEDYREPACK INC.(829572556)

PRINCIPAL DISPLAY PANEL

DRUG: Chlordiazepoxide Hydrochloride

GENERIC: Chlordiazepoxide Hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-1752-0

NDC: 70518-1752-1

COLOR: black

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: barr;033

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • CHLORDIAZEPOXIDE HYDROCHLORIDE 10mg in 1

INACTIVE INGREDIENT(S):

  • LECITHIN, SOYBEAN
  • SODIUM LAURYL SULFATE
  • SODIUM
  • PROPYLPARABEN
  • METHYLPARABEN
  • FD&C RED NO. 40
  • ETHYLENE GLYCOL MONOETHYL ETHER
  • DIMETHICONE
  • EDETATE CALCIUM DISODIUM
  • BUTYLPARABEN
  • TITANIUM DIOXIDE
  • SHELLAC
  • MICROCRYSTALLINE CELLULOSE
  • HYDROGENATED COTTONSEED OIL
  • GELATIN, UNSPECIFIED
  • FD&C BLUE NO. 1 ALUMINUM LAKE
  • FD&C BLUE NO. 1
  • D&C YELLOW NO. 10
  • SODIUM PROPIONATE
  • ANHYDROUS LACTOSE

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