Diclofenac potassium
These highlights do not include all the information needed to use DICLOFENAC POTASSIUM CAPSULES safely and effectively. See full prescribing information for DICLOFENAC POTASSIUM CAPSULES. DICLOFENAC potassium capsules, for oral use Initial U.S. Approval: 1988
Approved
Approval ID
d9685883-9d0b-81da-e053-2a95a90ab8d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2022
Manufacturers
FDA
TEVA PHARMACEUTICALS, INC.
DUNS: 022629579
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diclofenac potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0480-9435
Application NumberANDA204648
Product Classification
M
Marketing Category
C73584
G
Generic Name
diclofenac potassium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 4, 2022
FDA Product Classification
INGREDIENTS (15)
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW)Inactive
Code: 5WE8P977RQ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
DICLOFENAC POTASSIUMActive
Quantity: 25 mg in 1 1
Code: L4D5UA6CB4
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT