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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 CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959

Approved
Approval ID

3d1d4dde-1c7f-4a20-b8f8-897b1b284f80

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 14, 2023

Manufacturers
FDA

Calvin Scott & Co., Inc.

DUNS: 073404626

Products 1

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 Code17224-904
Application NumberANDA205008
Product Classification
M
Marketing Category
C73584
G
Generic Name
PHENTERMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMarch 14, 2023
FDA Product Classification

INGREDIENTS (9)

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
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB

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Phentermine hydrochloride - FDA Drug Approval Details