Phentermine Hydrochloride
PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV
Approved
Approval ID
a3600c42-470a-4a36-9e9a-d74504de8c40
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 10, 2010
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 Code10544-602
Application NumberANDA040527
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 10, 2010
FDA Product Classification
INGREDIENTS (2)
Phentermine HydrochlorideActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
povidoneInactive
Code: FZ989GH94E
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 4/21/2010
Manufactured by:
MUTUAL PHARMACEUTICAL CO., INC.
Philadelphia, PA 19124 USA
Rev 01, February 2009