IBUPROFEN

Product NDC
0363-9611
11-digit product format
003639611
Labeler code
0363
Product ID
0363-9611_13eac335-12dc-1255-e063-6394a90a1ae1
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
WALGREENS
Application
ANDA091237
Marketing category
ANDA
Marketing start
2018-12-11
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0363-9611DDiscontinued by firm2026-08-17
excluded packagepackage0363-96110363-9611-01DDiscontinued by firm2026-08-17
excluded packagepackage0363-96110363-9611-05DDiscontinued by firm2026-08-17
excluded packagepackage0363-96110363-9611-10DDiscontinued by firm2026-08-17
excluded packagepackage0363-96110363-9611-31DDiscontinued by firm2026-08-17
excluded packagepackage0363-96110363-9611-50DDiscontinued by firm2026-08-17

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 · 84 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 packagepackage0363-9611-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-9611-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-9611-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-9611-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-9611-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-9611-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-9611-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-9611-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-9611-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-9611-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-9611-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-9611-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-9611-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-9611-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-9611-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-9611-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-9611-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-9611-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-9611-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-9611-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-9611-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-9611-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-9611-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-9611-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-9611-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-9611-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-9611-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-9611-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-9611-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-9611-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-9611-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-9611-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-9611-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-9611-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-9611-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-9611-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-9611-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-9611-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-9611-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-9611-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-9611-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-9611-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-9611-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-9611-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-9611-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-9611-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-9611-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-9611-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-9611-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-9611-01ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091237-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-08

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083f01610625f2…
2019-09-15 20:21 UTC2019-09A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
IBUPROFEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310965Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
76f4cc25-a77e-6245-e053-2a91aa0af7aeAvailable on FDA.report

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
0363-9611-01IBUPROFEN100 in 1 BOTTLE, PLASTICTABLET1004
0363-9611-05IBUPROFEN50 in 1 BOTTLE, PLASTICTABLET504
0363-9611-10IBUPROFEN1000 in 1 BOTTLE, PLASTICTABLET10004
0363-9611-31IBUPROFEN300 in 1 BOTTLE, PLASTICTABLET3004
0363-9611-50IBUPROFEN500 in 1 BOTTLE, PLASTICTABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9611IBUPROFEN TABLET [WALGREENS]4Current NDC, Legacy NDC, 5 package rows20240320_76f4cc25-a77e-6245-e053-2a91aa0af7ae.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENCVS Pharmacy. Inc.d4336a7c-fb9f-1fbe-e053-2995a90af3652025-09-13WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IbuprofenIBUPROFENCVS Pharmacy.Inc.cd0c3404-9e9d-bfad-e053-2995a90a87192025-09-13WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IBUPROFENIBUPROFENTIME CAP LABORATORIES,INC82aad715-f652-471b-840c-5151c66e5ade2024-08-28WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IbuprofenIBUPROFEN TABLETS USP, 200MGKROGER COMPANY0fbe42d0-b5f2-0780-e063-6394a90a4ecb2024-04-13WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IBUPROFENIBUPROFENWALGREENS76f4cc25-a77e-6245-e053-2a91aa0af7ae2024-03-18WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
ndc (product): 0363-9611
IBUPROFENIBUPROFENWALGREENS76f15be2-4682-5015-e053-2991aa0af0d22024-03-15WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IBUPROFENIBUPROFENTARGET CORPORATION8e872c8d-28e2-cd49-e053-2995a90a469f2024-01-03WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IbuprofenIBUPROFEN TABLETS USP, 200MGBETTER LIVING BRANDS, LLCeb60a1e5-fb6e-360f-e053-2a95a90ade042023-08-03WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IbuprofenIBUPROFENCARDINAL HEALTHdfbbde4f-633d-6d57-e053-2a95a90ad82f2022-05-24WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IBUPROFENIBUPROFENRITE AIDa7abf95e-d444-42da-e053-2995a90a88d32022-01-03WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IBUPROFENIBUPROFENRITE AIDa7ac8b55-2758-400e-e053-2995a90a0eed2022-01-03WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237
IbuprofenIBUPROFENMARKSANS PHARMA LIMITED859d7190-586f-4766-a7e7-9e800a72d58b2021-12-21WarningsExact identifier
application applno (ANDA): 091237
application number: ANDA091237

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN76f4cc25-a77e-6245-e053-2a91aa0af7ae4
310965ibuprofen 200 MG Oral TabletSCD76f4cc25-a77e-6245-e053-2a91aa0af7ae4
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY76f4cc25-a77e-6245-e053-2a91aa0af7ae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9611-0100363961101100 TABLET in 1 BOTTLE, PLASTIC (0363-9611-01) 100 tablet2018-12-110000-00-00NoNoCurrent
0363-9611-050036396110550 TABLET in 1 BOTTLE, PLASTIC (0363-9611-05) 50 tablet2018-12-110000-00-00NoNoCurrent
0363-9611-10003639611101000 TABLET in 1 BOTTLE, PLASTIC (0363-9611-10) 1000 tablet2018-12-110000-00-00NoNoCurrent
0363-9611-3100363961131300 TABLET in 1 BOTTLE, PLASTIC (0363-9611-31) 300 tablet2018-12-110000-00-00NoNoCurrent
0363-9611-5000363961150500 TABLET in 1 BOTTLE, PLASTIC (0363-9611-50) 500 tablet2018-12-110000-00-00NoNoCurrent