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

c61df58d-d6bb-4d3e-9ef8-60caa7d4e762

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 5, 2023

Manufacturers

FDA

Micro Labs Limited

DUNS: 862174955

Products 2

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

Diclofenac Sodium/Misoprostol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42571-133

Application NumberANDA204355

Product Classification

Marketing Category

C73584

Generic Name

Diclofenac Sodium/Misoprostol

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 5, 2023

FDA Product Classification

INGREDIENTS (15)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

DICLOFENAC SODIUMActive

Quantity: 50 mg in 1 1

Code: QTG126297Q

Classification: ACTIB

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

MISOPROSTOLActive

Quantity: 200 ug in 1 1

Code: 0E43V0BB57

Classification: ACTIB

Diclofenac Sodium/Misoprostol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42571-134

Application NumberANDA204355

Product Classification

Marketing Category

C73584

Generic Name

Diclofenac Sodium/Misoprostol

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 5, 2023

FDA Product Classification

INGREDIENTS (15)

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEY

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32I

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

DICLOFENAC SODIUMActive

Quantity: 75 mg in 1 1

Code: QTG126297Q

Classification: ACTIB

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

MISOPROSTOLActive

Quantity: 200 ug in 1 1

Code: 0E43V0BB57

Classification: ACTIB

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Diclofenac Sodium/Misoprostol

Products 2

Diclofenac Sodium/Misoprostol

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Diclofenac Sodium/Misoprostol

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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