Diclofenac Sodium
These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1% for topical use only Initial U.S. Approval: 1988
Approved
Approval ID
0ed15330-5883-4e70-a03c-2823b7c8a86e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2023
Manufacturers
FDA
Gabar Health Sciences Corp
DUNS: 118401847
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diclofenac Sodium Topical Gel, 1%,
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82429-314
Application NumberANDA210986
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium Topical Gel, 1%,
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (9)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
CARBOMER HOMOPOLYMER TYPE CInactive
Code: 4Q93RCW27E
Classification: IACT
COCO-CAPRYLATE/CAPRATEInactive
Code: 8D9H4QU99H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 10 mg in 1 g
Code: QTG126297Q
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT