Phentermine hydrochloride
These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIVPHENTERMINE hydrochloride tablets USP, for oral use CIVInitial U.S. Approval: 1959
Approved
Approval ID
50efa498-11c5-41fa-95ac-419fcc10da03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-1229
Application NumberANDA205008
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 27, 2023
Generic Namephentermine hydrochloride
INGREDIENTS (9)
PHENTERMINE HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT