Phentermine Hydrochloride
Initial U.S. Approval: 1959
Approved
Approval ID
680c1aba-760e-40a0-949d-b03448e1cf3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 20, 2022
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-3175
Application NumberANDA040886
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2018
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT