FDA.reportPublic FDA data

Diclofenac Sodium and Misoprostol

Product NDC
42291-232
Requested package NDC
42291-232-90
11-digit product format
422910232
Labeler code
42291
Product ID
42291-232_4dc7edc1-b426-ac49-e063-6294a90af71b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium and Misoprostol
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA201089
Marketing category
ANDA
Marketing start
2012-12-14
Substance
DICLOFENAC SODIUM; MISOPROSTOL
Active strength
50; 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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42291-23242291-232-90DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A201089-001DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09
A201089-002DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201089-001AB
A201089-002AB

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 UTC2026-02A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201089-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A201089-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALAB2012-07-09782e0a99824c…

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 UTC2026-02A201089-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201089-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201089-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201089-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201089-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201089-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201089-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201089-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201089-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201089-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201089-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201089-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201089-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201089-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201089-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201089-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201089-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201089-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201089-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201089-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201089-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201089-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201089-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201089-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201089-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201089-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201089-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201089-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201089-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201089-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201089-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201089-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201089-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201089-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201089-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201089-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201089-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201089-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201089-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201089-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium and Misoprostol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM50 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
0E43V0BB57Internal UNII lookup
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857706Internal RxNorm lookup
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
3643ab1b-9f8f-b2f4-e02d-950d0a02e587Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-232-60Diclofenac Sodium and Misoprostol60 in 1 BOTTLETABLET, DELAYED RELEASE609
42291-232-90Diclofenac Sodium and Misoprostol90 in 1 BOTTLETABLET, DELAYED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-232-60EA - Each42291-23221a8a397-5e0c-482f-810d-56459e957ddb12016-11-08
42291-232-90EA - Each42291-2325904e57a-45db-4c9e-9089-24dceffdc88112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
MISOPROSTOLACTIVE MOIETY0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-232DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [AVKARE]7Current NDC, Legacy NDC, 2 package rows20220904_3643ab1b-9f8f-b2f4-e02d-950d0a02e587.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAvKARE3643ab1b-9f8f-b2f4-e02d-950d0a02e5872026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201089
application number: ANDA201089
ndc (package): 42291-232-90
ndc (product): 42291-232
ndc11 (package): 42291023290
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBluePoint Laboratories9a22cb4b-e49a-4bd7-b235-47405c3026582025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201089
application number: ANDA201089
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLActavis Pharma, Inc.df8b8660-0c24-4848-8bea-c1b935090c662025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201089
application number: ANDA201089

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857706diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
857706diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
857706diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
857706diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral TabletSY3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY3643ab1b-9f8f-b2f4-e02d-950d0a02e5879

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-232-904229102329090 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-232-90) 2012-12-140000-00-00NoNoCurrent