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
0ee5b71b-3d8e-46d0-937d-2dbe43490e33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2012
Manufacturers
FDA
Mutual Pharmaceutical Company, Inc.
DUNS: 121735955
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 Code53489-406
Application NumberANDA040526
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2012
FDA Product Classification
INGREDIENTS (9)
crospovidoneInactive
Code: 68401960MK
Classification: IACT
Phentermine HydrochlorideActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
calcium phosphate, dibasic, dihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
povidonesInactive
Code: FZ989GH94E
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT