Ibuprofen (NSAID)

Product NDC
21695-065
11-digit product format
216950065
Labeler code
21695
Product ID
21695-065_7b4858fc-fea6-4e4c-886e-a2febe1ed2c3
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen (NSAID)
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA071333
Marketing category
ANDA
Marketing start
2009-12-16
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-065IInactivated by FDA2026-10-05
excluded packagepackage21695-06521695-065-06IInactivated by FDA2026-10-05
excluded packagepackage21695-06521695-065-14IInactivated by FDA2026-10-05
excluded packagepackage21695-06521695-065-28IInactivated by FDA2026-10-05
excluded packagepackage21695-06521695-065-30IInactivated by FDA2026-10-05
excluded packagepackage21695-06521695-065-50IInactivated by FDA2026-10-05
excluded packagepackage21695-06521695-065-60IInactivated by FDA2026-10-05
excluded packagepackage21695-06521695-065-90IInactivated 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 3 · 176 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 packagepackage21695-065-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-065-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-065-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-065-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-065-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-065-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-065-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-065-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-065-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-065-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-065-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-065-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-065-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-065-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-065-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-065-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-065-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-065-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-065-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-065-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-065-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-065-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-065-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-065-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-065-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-065-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-065-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-065-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-065-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-065-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-065-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-065-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-065-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-065-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-065-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-065-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-065-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-065-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-065-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-065-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-065-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-065-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-065-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-065-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-065-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-065-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-065-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-065-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-065-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-065-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-065-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-065-50ed331223b511…672a5bd82f5f…

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
21695-065-06Ibuprofen (NSAID)Pain Releiver/ Fever Reducer6 in 1 BOTTLETABLET61
21695-065-14Ibuprofen (NSAID)Pain Releiver/ Fever Reducer14 in 1 BOTTLETABLET141
21695-065-28Ibuprofen (NSAID)Pain Releiver/ Fever Reducer28 in 1 BOTTLETABLET281
21695-065-30Ibuprofen (NSAID)Pain Releiver/ Fever Reducer30 in 1 BOTTLETABLET301
21695-065-50Ibuprofen (NSAID)Pain Releiver/ Fever Reducer50 in 1 BOTTLETABLET501
21695-065-60Ibuprofen (NSAID)Pain Releiver/ Fever Reducer60 in 1 BOTTLETABLET601
21695-065-90Ibuprofen (NSAID)Pain Releiver/ Fever Reducer90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-065-14EA - Each21695-065ec67d892-4165-4604-83f6-1eaeb524c03d12012-07-24
21695-065-28EA - Each21695-065132a04d6-ba56-4a5f-8c3e-659bf946031112012-07-24
21695-065-30EA - Each21695-065f03a3aba-b664-4918-ab1d-de9d584a2bc012012-07-24
21695-065-50EA - Each21695-065a5c3bc78-46f9-4fd0-a3ba-8c8e6f09a4ac12012-07-24
21695-065-60EA - Each21695-06545ddc4d8-2a68-4c6a-9ad2-0de1f006cc6712012-07-24
21695-065-90EA - Each21695-065881ed50b-4a37-4d56-8893-94ea6e9c176312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-065IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 7 package rows20110629_7b4858fc-fea6-4e4c-886e-a2febe1ed2c3.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 TabletPSN7b4858fc-fea6-4e4c-886e-a2febe1ed2c31
310965ibuprofen 200 MG Oral TabletSCD7b4858fc-fea6-4e4c-886e-a2febe1ed2c31
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY7b4858fc-fea6-4e4c-886e-a2febe1ed2c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-065-06216950065066 in 1 BOTTLEHistorical
21695-065-142169500651414 in 1 BOTTLEHistorical
21695-065-282169500652828 in 1 BOTTLEHistorical
21695-065-302169500653030 in 1 BOTTLEHistorical
21695-065-502169500655050 in 1 BOTTLEHistorical
21695-065-602169500656060 in 1 BOTTLEHistorical
21695-065-902169500659090 in 1 BOTTLEHistorical