MedPath
FDA Product

Phentermine Hydrochloride

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

Basic Information

Phentermine Hydrochloride

68788-7740

Regulatory Information

68788-7740

ANDA205019

C73584

August 25, 2023

USA

These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE hydrochloride capsules USP, for oral use CIVInitial U.S. Approval: 1959

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

791119022

Active Ingredients

PHENTERMINE HYDROCHLORIDE

Quantity: 15 mg in 1 1

Code: 0K2I505OTV

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

FD&C RED NO. 3

Code: PN2ZH5LOQY

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

FD&C YELLOW NO. 5

Code: I753WB2F1M

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

Active Moieties

PHENTERMINE

Code: C045TQL4WP

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