Phentermine Hydrochloride

Basic Information

Product Name

FDA Product Code

53489-406

Regulatory Information

NDC Product Code

53489-406

Application Number

ANDA040526

Marketing Category

C73584

Effective Date

June 30, 2012

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. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

crospovidone

Code: 68401960MK

Class Code: IACT

Phentermine Hydrochloride

Quantity: 37.5 mg in 1 1

Code: 0K2I505OTV

Class Code: ACTIB

FD&C Blue No. 1

Code: H3R47K3TBD

Class Code: IACT

calcium phosphate, dibasic, dihydrate

Code: O7TSZ97GEP

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

povidones

Code: FZ989GH94E

Class Code: IACT

shellac

Code: 46N107B71O

Class Code: IACT

propylene glycol

Code: 6DC9Q167V3

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

Phentermine

Code: C045TQL4WP

Basic Information

Regulatory Information

Company Information

Active Ingredients

crospovidone

FD&C Blue No. 1

calcium phosphate, dibasic, dihydrate

magnesium stearate

povidones

shellac

propylene glycol

titanium dioxide

Active Moieties

Phentermine