FDA Product

Phentermine Hydrochloride

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

Basic Information

Product Name

Phentermine Hydrochloride

FDA Product Code

55289-701

Regulatory Information

NDC Product Code

55289-701

Application Number

ANDA040876

Marketing Category

C73584

Effective Date

March 12, 2024

Territorial Authority

USA

FDA Title

Initial U.S. Approval: 1959

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

19

Company Information

ManufacturerPD-Rx Pharmaceuticals, Inc.

DUNS Number

156893695

Active Ingredients

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

PHENTERMINE HYDROCHLORIDE

Quantity: 37.5 mg in 1 1

Code: 0K2I505OTV

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

Active Moieties

PHENTERMINE

Code: C045TQL4WP

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