Diclofenac Sodium
Diclofenac Sodium
Approved
Approval ID
89ccfc76-245f-4604-bc1d-9115c657c340
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diclofenac Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-5370
Application NumberANDA075185
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2017
FDA Product Classification
INGREDIENTS (13)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL 2000Inactive
Code: HAF0412YIT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 50 mg in 1 1
Code: QTG126297Q
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Diclofenac Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-5360
Application NumberANDA075185
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2017
FDA Product Classification
INGREDIENTS (13)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 2000Inactive
Code: HAF0412YIT
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 75 mg in 1 1
Code: QTG126297Q
Classification: ACTIB