NDC Code(s) : 51079-374-01, 51079-374-20, 51079-375-01, 51079-375-20, 51079-141-01, 51079-141-20
Packager : Mylan Institutional 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:51079-374(NDC:0555-0158)
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 HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
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)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C RED NO. 40(UNII: WZB9127XOA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
Product Characteristics
Color green (aqua green), yellow Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code barr;158
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-374-20100 in 1 CARTON 26/05/2022
1NDC:51079-374-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084768 05/26/2022
Chlordiazepoxide HydrochlorideChlordiazepoxide Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-375(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
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)
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)
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:51079-375-20100 in 1 CARTON 26/05/2022
1NDC:51079-375-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083116 05/26/2022
Chlordiazepoxide HydrochlorideChlordiazepoxide Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-141(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)
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)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
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 barr;159
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-141-20100 in 1 CARTON 06/01/2022
1NDC:51079-141-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084769 06/01/2022

LABELER - Mylan Institutional Inc.(039615992)

PRINCIPAL DISPLAY PANEL

NDC 51079-374-20

Chlordiazepoxide
Hydrochloride Capsules, USP
5 mg
C-IV

100 Capsules (10 x 10)

Each capsule contains 5 mg
chlordiazepoxide hydrochloride, USP.

Usual Dosage:See accompanying
prescribing information and
Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See USP
Controlled Room Temperature] in a dry place.
Protect from light.

Manufactured for:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rx only

S-12851

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Chlordiazepoxide HCl 5 mg Capsules C-IV Unit Carton LabelChlordiazepoxide HCl 5 mg Capsules C-IV Unit Carton Label

PRINCIPAL DISPLAY PANEL

NDC 51079-375-20

Chlordiazepoxide
Hydrochloride Capsules, USP
10 mg
C-IV

100 Capsules (10 x 10)

Each capsule contains 10 mg
chlordiazepoxide hydrochloride, USP.

Usual Dosage:See accompanying
prescribing information and
Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See USP
Controlled Room Temperature] in a dry place.
Protect from light.

Manufactured for:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rx only

S-12852

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.
Chlordiazepoxide HCl 10 mg Capsules C-IV Unit Carton Label

Chlordiazepoxide HCl 10 mg Capsules C-IV Unit Carton Label

PRINCIPAL DISPLAY PANEL

NDC 51079-141-20

Chlordiazepoxide
Hydrochloride Capsules, USP
25 mg
C-IV

100 Capsules (10 x 10)

Each capsule contains 25 mg
chlordiazepoxide hydrochloride, USP.

Usual Dosage:See accompanying
prescribing information and
Medication Guide.

Store at 20° to 25°C (68° to 77°F). [See USP
Controlled Room Temperature] in a dry place.
Protect from light.

Manufactured for:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rx only

S-12853

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Chlordiazepoxide HCl 25 mg Capsules C-IV Unit Carton LabelChlordiazepoxide HCl 25 mg Capsules C-IV Unit Carton Label