Phentermine
These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959
Approved
Approval ID
8229adf5-b128-41a5-a3cc-16db4001801c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 2
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 Code50090-3282
Application NumberANDA204318
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2019
Generic NamePhentermine Hydrochloride
INGREDIENTS (16)
PHENTERMINE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Phentermine Hydrochloride
PRODUCT DETAILS
NDC Product Code50090-3306
Application NumberANDA204318
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2019
Generic NamePhentermine Hydrochloride
INGREDIENTS (13)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT