equate ibuprofen

Product NDC
49035-684
Requested package NDC
49035-684-85
11-digit product format
490350684
Labeler code
49035
Product ID
49035-684_4b03aa7c-0aca-4a33-b6d3-1b378b38a230
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA202312
Marketing category
ANDA
Marketing start
2020-12-29
Marketing end
0000-00-00
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49035-68449035-684-85DDiscontinued 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 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49035-68449035-684-85DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49035-68449035-684-85DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A202312-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2016-10-07

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 06:07:402026-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073f01610625f2…
2019-09-15 20:21 UTC2019-09A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07e64feba35796…

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENShield Pharmaceuticals Corp22102461-0196-4ef0-aef4-66997d74d1182026-08-10WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENHarris Teeter637210f0-6494-4656-8b2b-14d7476cb1272026-07-29WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IBUPROFENIBUPROFENHarris Teeter14515409-736f-4119-b6a0-cb19ee2e948e2026-07-29WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IBUPROFENIBUPROFENGranules India Limited97516b9f-219a-429d-850d-1fe9fd66646b2026-06-15WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENHYVEE INC459fc063-0664-09b7-e063-6394a90a89e02026-01-13WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENHYVEE INC459fc670-32a3-61a6-e063-6294a90aea5a2026-01-13WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES,LLC.a568fd1e-9bf0-3c03-e053-2a95a90a45b72025-12-19WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c85b-2ba5-32c3-e063-6294a90af1482025-12-19WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENWalgreens07edb8d0-2fa8-4b40-e063-6294a90a2fe92025-12-19WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.a3c1a61b-88fc-419c-e053-2a95a90ac0c32025-12-18WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANYa42f96c4-322d-4714-9435-7b5a4e8b6ae52025-12-11WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY36b95840-f621-437a-bf49-406d320964da2025-12-11WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC9c1ded4e-1d3b-1ab6-e053-2995a90aa80d2025-12-10WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC9c1cc205-b9e3-03fc-e053-2995a90aaffb2025-12-10WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IBUPROFENIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f40f5-625d-3f2e-e053-2a95a90a438b2025-11-18WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f42a7-c2d8-4a51-e053-2a95a90a16772025-11-18WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENDemoulas Super Markets, Inc39802e26-1028-d2fe-e063-6394a90a24c72025-07-16WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENMarc Glassman, Inc.9714e804-fadb-103d-e053-2a95a90ad7652025-07-15WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENMARC GLASSMAN, INC.9714de6b-068b-d6b9-e053-2995a90a3b272025-07-15WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI8fecb3a8-d288-cacf-e053-2a95a90ae2382025-07-01WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-684-85490350684851 BOTTLE in 1 CARTON (49035-684-85) > 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-12-290000-00-00NoNoCurrent