DICLOFENAC SODIUM
Approved
Approval ID
5fd9467f-9138-f7c9-e053-2a91aa0a5ef0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2017
Manufacturers
FDA
H. J. Harkins Company Inc.
DUNS: 147681894
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 Code76519-1159
Application NumberANDA208077
Product Classification
M
Marketing Category
C73584
G
Generic Name
DICLOFENAC
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 8, 2017
FDA Product Classification
INGREDIENTS (9)
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 10 mg in 1 1
Code: QTG126297Q
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
COCO-CAPRYLATE/CAPRATEInactive
Code: 8D9H4QU99H
Classification: IACT