FDA.reportPublic FDA data

Diclofenac Sodium and Misoprostol

Product NDC
71335-1183
Requested package NDC
71335-1183-5
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-118371335-1183-5IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-118371335-1183-5IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203995-001DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25
A203995-002DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203995-001AB
A203995-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203995-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A203995-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2016-11-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203995-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203995-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203995-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203995-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203995-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203995-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203995-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203995-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203995-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203995-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203995-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203995-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203995-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203995-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203995-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203995-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203995-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203995-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203995-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203995-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203995-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203995-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203995-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203995-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203995-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203995-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203995-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203995-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203995-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203995-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203995-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203995-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203995-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203995-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203995-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203995-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203995-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203995-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203995-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203995-002AB1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup
0E43V0BB57Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359105Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6671b66-00ad-4949-b51a-36e1130b1cb5Available on FDA.report

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, Related label table
NDCEffectiveRelated label
71335-1183-12024-05-20These 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
71335-1183-22024-05-20These 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
71335-1183-32024-05-20These 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
71335-1183-42024-05-20These 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
71335-1183-52024-05-20These 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
71335-1183-12024-01-30These 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
71335-1183-22024-01-30These 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
71335-1183-32024-01-30These 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
71335-1183-42024-01-30These 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
71335-1183-52024-01-30These 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAmneal Pharmaceuticals LLCafd30051-8f59-474b-9972-962a5a871dfb2025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203995
application number: ANDA203995
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepackd6671b66-00ad-4949-b51a-36e1130b1cb52025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203995
application number: ANDA203995
ndc (package): 71335-1183-5
ndc (product): 71335-1183
ndc11 (package): 71335118305

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
71335-1183-57133511830510 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1183-5) 2025-01-290000-00-00NoNoCurrent