Nabumetone
Rx Only
Approved
Approval ID
7b547af0-7be4-4277-8064-1bf1925154bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 22, 2019
Manufacturers
FDA
Amneal Pharmaceuticals of New York LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nabumetone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1658
Application NumberANDA075189
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumetone
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2019
FDA Product Classification
INGREDIENTS (14)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
NABUMETONEActive
Quantity: 750 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Nabumetone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1657
Application NumberANDA075189
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nabumetone
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2019
FDA Product Classification
INGREDIENTS (11)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
NABUMETONEActive
Quantity: 500 mg in 1 1
Code: LW0TIW155Z
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT