FDA Product

Clonazepam

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Clonazepam

FDA Product Code

68071-2954

Regulatory Information

NDC Product Code

68071-2954

Application Number

ANDA077856

Marketing Category

C73584

Effective Date

March 28, 2023

Territorial Authority

USA

FDA Title

CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerNuCare Pharmaceuticals,Inc.

DUNS Number

010632300

Active Ingredients

Quantity: 1 mg in 1 1

Code: 5PE9FDE8GB

Class Code: ACTIB

Inactive Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

Active Moieties

CLONAZEPAM

Code: 5PE9FDE8GB

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