Phentermine hydrochloride

These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIVPHENTERMINE hydrochloride tablets USP, for oral use CIVInitial U.S. Approval: 1959

Approved

Approval ID

43024f64-2d77-49a9-80fd-ad07a86c69a3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 14, 2022

Manufacturers

FDA

SUNRISE PHARMACEUTICAL, INC.

DUNS: 168522378

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

phentermine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code11534-160

Application NumberANDA205008

Product Classification

Marketing Category

C73584

Generic Name

phentermine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateApril 10, 2017

FDA Product Classification

INGREDIENTS (9)

PHENTERMINE HYDROCHLORIDEActive

Quantity: 37.5 mg in 1 1

Code: 0K2I505OTV

Classification: ACTIB

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

phentermine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code11534-159

Application NumberANDA205017

Product Classification

Marketing Category

C73584

Generic Name

phentermine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateApril 10, 2017

FDA Product Classification

INGREDIENTS (19)

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PHENTERMINE HYDROCHLORIDEActive

Quantity: 37.5 mg in 1 1

Code: 0K2I505OTV

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

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Phentermine hydrochloride

Products 2

phentermine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (9)

phentermine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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