ZIPSOR
These highlights do not include all the information needed to use ZIPSOR safely and effectively. See full prescribing information for ZIPSOR. ZIPSOR (diclofenac potassium) 25 mg capsule, for oral useInitial U.S. Approval: 1988
Approved
Approval ID
c982eca0-fc41-11e1-a9c8-0002a5d5c51b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2021
Manufacturers
FDA
Assertio Therapeutics, Inc.
DUNS: 937562890
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 Code13913-008
Application NumberNDA022202
Product Classification
M
Marketing Category
C73594
G
Generic Name
diclofenac potassium
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2019
FDA Product Classification
INGREDIENTS (10)
DICLOFENAC POTASSIUMActive
Quantity: 25 mg in 1 1
Code: L4D5UA6CB4
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT