Diclofenac Sodium
Approved
Approval ID
fc08e58c-6323-e667-e053-6394a90ab754
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 21, 2025
Manufacturers
FDA
GERI-CARE PHARMACEUTICAL CORP
DUNS: 611196254
Products 1
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 Code57896-147
Application NumberANDA204306
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 21, 2025
FDA Product Classification
INGREDIENTS (9)
DICLOFENAC SODIUMActive
Quantity: 10 mg in 1 g
Code: QTG126297Q
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
COCOYL CAPRYLOCAPRATEInactive
Code: 8D9H4QU99H
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT