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
0b7ad9c0-9e1e-4a69-802b-28f44267e34d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2017
Manufacturers
FDA
Elite Laboratories, Inc.
DUNS: 785398728
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 Code64850-810
Application NumberANDA040190
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2019
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT