Phentermine Hydrochloride
These highlights do not include all the information needed to use phentermine hydrochloride tablets USP safely and effectively. See full prescribing information for phentermine hydrochloride tablets USP. PHENTERMINE Hydrochloride Tablets USP CIV for oral use Initial U.S. Approval: 1959
Approved
Approval ID
735d1c5f-ee7e-45c7-9f1a-458577498173
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2015
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-552
Application NumberANDA040526
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2015
FDA Product Classification
INGREDIENTS (6)
crospovidoneInactive
Code: 68401960MK
Classification: IACT
calcium phosphate, dibasic, dihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Phentermine HydrochlorideActive
Quantity: 30 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIM
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
povidonesInactive
Code: FZ989GH94E
Classification: IACT