Phentermine Hydrochloride

Basic Information

Product Name

FDA Product Code

76420-057

Regulatory Information

NDC Product Code

76420-057

Application Number

ANDA040555

Marketing Category

C73584

Effective Date

October 12, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use phentermine hydrochloride tablets, USP safely and effectively. See full prescribing information for . PHENTERMINE Hydrochloride Tablets, USP for oral use CIV Initial U.S. Approval: 1959

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

PHENTERMINE HYDROCHLORIDE

Quantity: 37.5 mg in 1 1

Code: 0K2I505OTV

Class Code: ACTIB

SUCROSE

Code: C151H8M554

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

PHENTERMINE

Code: C045TQL4WP

Basic Information

Regulatory Information

Company Information

Active Ingredients

MAGNESIUM STEARATE

STARCH, CORN

ANHYDROUS LACTOSE

FD&C BLUE NO. 1

SUCROSE

ALUMINUM OXIDE

CELLULOSE, MICROCRYSTALLINE

Active Moieties

PHENTERMINE