FDA.reportPublic FDA data

Diclofenac Sodium and Misoprostol

Product NDC
71335-1183
11-digit product format
713351183
Labeler code
71335
Product ID
71335-1183_3c1e7d73-b9c0-4260-87ed-049797c1e8dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium and Misoprostol
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203995
Marketing category
ANDA
Marketing start
2016-12-01
Substance
DICLOFENAC SODIUM; MISOPROSTOL
Active strength
75; 200 mg/1; ug/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium and Misoprostol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1
MISOPROSTOL200 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q, 0E43V0BB57
Rxcui1359105

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9Product name320231221
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1183-12024-05-20C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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
71335-1183-22024-05-20C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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
71335-1183-32024-05-20C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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
71335-1183-42024-05-20C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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
71335-1183-52024-05-20C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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
71335-1183-12024-01-30C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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
71335-1183-22024-01-30C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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
71335-1183-32024-01-30C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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
71335-1183-42024-01-30C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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
71335-1183-52024-01-30C16284748780-11030e365-176e-111a-e063-dadaa90a10e2These 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1183-1Diclofenac Sodium and Misoprostol20 in 1 BOTTLETABLET, DELAYED RELEASE204
71335-1183-2Diclofenac Sodium and Misoprostol14 in 1 BOTTLETABLET, DELAYED RELEASE144
71335-1183-3Diclofenac Sodium and Misoprostol60 in 1 BOTTLETABLET, DELAYED RELEASE604
71335-1183-4Diclofenac Sodium and Misoprostol30 in 1 BOTTLETABLET, DELAYED RELEASE304
71335-1183-5Diclofenac Sodium and Misoprostol10 in 1 BOTTLETABLET, DELAYED RELEASE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1183DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 5 package rows20250224_d6671b66-00ad-4949-b51a-36e1130b1cb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSNd6671b66-00ad-4949-b51a-36e1130b1cb54
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCDd6671b66-00ad-4949-b51a-36e1130b1cb54
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSYd6671b66-00ad-4949-b51a-36e1130b1cb54
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSYd6671b66-00ad-4949-b51a-36e1130b1cb54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1183-17133511830120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-1) 2025-01-290000-00-00NoNoCurrent
71335-1183-27133511830214 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-2) 2019-04-100000-00-00NoNoCurrent
71335-1183-37133511830360 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-3) 2025-01-290000-00-00NoNoCurrent
71335-1183-47133511830430 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-4) 2025-01-290000-00-00NoNoCurrent
71335-1183-57133511830510 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-5) 2025-01-290000-00-00NoNoCurrent