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 Initial U.S. Approval: 1959
Approved
Approval ID
1d1d27e7-7ef9-4c74-809a-695111208430
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2022
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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
NDC Product Code50090-4216
Application NumberANDA203068
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 1, 2017
Generic NamePhentermine Hydrochloride
INGREDIENTS (9)
PHENTERMINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT