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, for oral use CIVInitial U.S. Approval: 1959
Approved
Approval ID
a0439c85-5ede-4e02-aed2-47debd2c8eb2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2022
Manufacturers
FDA
SUNRISE PHARMACEUTICAL, INC.
DUNS: 168522378
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 Code11534-157
Application NumberANDA205019
Product Classification
M
Marketing Category
C73584
G
Generic Name
phentermine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2017
FDA Product Classification
INGREDIENTS (18)
PHENTERMINE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
phentermine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11534-176
Application NumberANDA205019
Product Classification
M
Marketing Category
C73584
G
Generic Name
phentermine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2017
FDA Product Classification
INGREDIENTS (17)
PHENTERMINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT