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
ee02f939-58df-4f2e-86ce-122893255265
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2020
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diclofenac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-0371
Application NumberANDA208077
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2018
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
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
COCO-CAPRYLATE/CAPRATEInactive
Code: 8D9H4QU99H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT