Phentermine Hydrochloride
These highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959
Approved
Approval ID
350cb4d3-bd67-4613-bde2-16208221d957
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2017
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-6760
Application NumberANDA040526
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 23, 2017
FDA Product Classification
INGREDIENTS (6)
PHENTERMINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT