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, for oral use CIV Initial U.S. Approval: 1959
Approved
Approval ID
e47dc31f-9548-403e-940f-a5380f938aed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2020
Manufacturers
FDA
POLYGEN PHARMACEUTICALS INC.
DUNS: 962415720
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 Code52605-022
Application NumberANDA206342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2020
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT