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Diclofenac Sodium Misoprostol

These highlights do not include all the information needed to use DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS. DICLOFENAC SODIUM AND MISOPROSTOL delayed-release tablets, for oral use  Initial U.S. Approval:1997

Approved
Approval ID

2acf46ac-8ba8-444d-b421-19d5ad49644c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 2, 2023

Manufacturers
FDA

Nivagen Pharmaceuticals, Inc.

DUNS: 052032418

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

diclofenac sodium and misoprostol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75834-265
Application NumberANDA205143
Product Classification
M
Marketing Category
C73584
G
Generic Name
diclofenac sodium and misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2022
FDA Product Classification

INGREDIENTS (15)

MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
DICLOFENAC SODIUMActive
Quantity: 75 mg in 1 1
Code: QTG126297Q
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT

diclofenac sodium and misoprostol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75834-264
Application NumberANDA205143
Product Classification
M
Marketing Category
C73584
G
Generic Name
diclofenac sodium and misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2022
FDA Product Classification

INGREDIENTS (15)

DICLOFENAC SODIUMActive
Quantity: 50 mg in 1 1
Code: QTG126297Q
Classification: ACTIB
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT

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Diclofenac Sodium Misoprostol - FDA Drug Approval Details