IBUPROFEN

Product NDC
12634-860
11-digit product format
126340860
Labeler code
12634
Product ID
12634-860_6e315790-ef94-4772-8e76-2565f8b097d4
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA071333
Marketing category
ANDA
Marketing start
2009-09-16
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct12634-860IInactivated by FDA2026-10-05
excluded packagepackage12634-86012634-860-01IInactivated by FDA2026-10-05
excluded packagepackage12634-86012634-860-10IInactivated by FDA2026-10-05
excluded packagepackage12634-86012634-860-24IInactivated by FDA2026-10-05

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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-860-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-860-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage12634-860-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-860-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-860-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage12634-860-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-860-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-860-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage12634-860-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage12634-860-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage12634-860-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage12634-860-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage12634-860-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage12634-860-24cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage12634-860-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage12634-860-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage12634-860-24cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage12634-860-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage12634-860-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage12634-860-24302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage12634-860-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage12634-860-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage12634-860-24ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage12634-860-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage12634-860-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage12634-860-240efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage12634-860-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage12634-860-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage12634-860-24ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage12634-860-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage12634-860-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage12634-860-24367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage12634-860-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage12634-860-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage12634-860-24557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage12634-860-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage12634-860-108af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage12634-860-248af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage12634-860-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage12634-860-10834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage12634-860-24834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage12634-860-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage12634-860-101332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage12634-860-241332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage12634-860-011332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071333-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-02-17

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1784e616aacf4f…
2026-08-18 06:07:402026-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173f01610625f2…
2019-09-15 20:21 UTC2019-09A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071333-001IBUPROFEN200MGTABLET / ORAL1987-02-17f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-860-01IBUPROFEN100 in 1 BOTTLE, PLASTICTABLET1003
12634-860-10IBUPROFEN1000 in 1 BOTTLE, PLASTICTABLET10003
12634-860-24IBUPROFEN24 in 1 BOTTLE, PLASTICTABLET243

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [APOTHECA INC.]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [APOTHECA INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKIBUPROFEN TABLET [APOTHECA INC.]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET [APOTHECA INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [APOTHECA INC.]3
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [APOTHECA INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [APOTHECA INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBUPROFEN TABLET [APOTHECA INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [APOTHECA INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JIBUPROFEN TABLET [APOTHECA INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [APOTHECA INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [APOTHECA INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-860IBUPROFEN TABLET [APOTHECA INC.]3Legacy NDC, 3 package rows20100224_a6e57acd-b02a-472e-9cc6-8d4aea246164.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen Pain Releiver/ Fever ReducerIBUPROFENAmneal Pharmaceuticals of New York LLCee241be0-35f8-4789-a71f-98de31d6a5902023-12-31WarningsExact identifier
application applno (ANDA): 071333
application number: ANDA071333

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNa6e57acd-b02a-472e-9cc6-8d4aea2461643
310965ibuprofen 200 MG Oral TabletSCDa6e57acd-b02a-472e-9cc6-8d4aea2461643
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYa6e57acd-b02a-472e-9cc6-8d4aea2461643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-860-0112634086001100 in 1 BOTTLE, PLASTICHistorical
12634-860-10126340860101000 in 1 BOTTLE, PLASTICHistorical
12634-860-241263408602424 in 1 BOTTLE, PLASTICHistorical