Phentermine Hydrochloride
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
Approved
Approval ID
58263978-0b92-5c86-e053-2a91aa0aa5e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2017
Manufacturers
FDA
Mas Management Group, Inc.
DUNS: 079363782
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 Code69677-293
Application NumberANDA200272
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2017
FDA Product Classification
INGREDIENTS (5)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT