Phentermine Hydrochloride
Initial U.S. Approval: 1959
Approved
Approval ID
f938b0ab-606e-8b21-e053-6294a90a4f4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2023
Manufacturers
FDA
Calvin Scott & Co., Inc.
DUNS: 073404626
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17224-877
Application NumberANDA040875
Product Classification
M
Marketing Category
C73584
G
Generic Name
PHENTERMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2023
FDA Product Classification
INGREDIENTS (9)
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT