Phentermine Resin
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . CIV Initial U.S. Approval: 1959
Approved
Approval ID
7ca86c66-409b-4852-8631-c3ada6e60738
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2017
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phentermine Resin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-1398
Application NumberANDA040872
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Resin
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2017
FDA Product Classification
INGREDIENTS (18)
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
PHENTERMINEActive
Quantity: 15 mg in 1 1
Code: C045TQL4WP
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
Phentermine Resin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-1366
Application NumberANDA040872
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Resin
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2017
FDA Product Classification
INGREDIENTS (18)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
PHENTERMINEActive
Quantity: 30 mg in 1 1
Code: C045TQL4WP
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT