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Diclofenac Sodium and 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

9a22cb4b-e49a-4bd7-b235-47405c302658

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 21, 2023

Manufacturers
FDA

BluePoint Laboratories

DUNS: 985523874

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 Code68001-231
Application NumberANDA201089
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium and Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2023
FDA Product Classification

INGREDIENTS (15)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
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
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB

Diclofenac Sodium and Misoprostol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68001-232
Application NumberANDA201089
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium and Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2023
FDA Product Classification

INGREDIENTS (15)

CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 75 mg in 1 1
Code: QTG126297Q
Classification: ACTIB
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB

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Diclofenac Sodium and Misoprostol - FDA Drug Approval Details