Phentermine Hydrochloride
These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP. PHENTERMINE Hydrochloride Capsules USP C IV Initial U.S. Approval: 1959
Approved
Approval ID
ceddcff6-b844-4285-acd5-198696c2e355
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0030
Application NumberANDA202248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2019
FDA Product Classification
INGREDIENTS (8)
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, TAPIOCAInactive
Code: 24SC3U704I
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Phentermine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0419
Application NumberANDA202248
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2019
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, TAPIOCAInactive
Code: 24SC3U704I
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT