PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE CAPSULES, USP CIV
Approved
Approval ID
c5b66bc3-13d9-4902-9719-a2d41b743c9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-185
Application NumberANDA087022
Product Classification
M
Marketing Category
C73584
G
Generic Name
PHENTERMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2010
FDA Product Classification
INGREDIENTS (17)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT