FDA.reportPublic FDA data

Ibuprofen

Product NDC
25000-135
11-digit product format
250000135
Labeler code
25000
Product ID
25000-135_e0bdfb43-8e4d-4ff4-9642-f3bd460b8465
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA091237
Marketing category
ANDA
Marketing start
2015-11-06
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091237-001IBUPROFEN200MGTABLET / 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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08cb3db0bc1861…

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
859d7190-586f-4766-a7e7-9e800a72d58bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25000-135-02Ibuprofen24 in 1 BOTTLETABLET247
25000-135-02Ibuprofen1 in 1 CARTONTABLET17
25000-135-03Ibuprofen30 in 1 BOTTLETABLET307
25000-135-14Ibuprofen1000 in 1 BOTTLETABLET10007
25000-135-30Ibuprofen6 in 1 BOXTABLET67
25000-135-30Ibuprofen6500 in 1 BAGTABLET65007
25000-135-70Ibuprofen500 in 1 BOTTLETABLET5007
25000-135-93Ibuprofen1 in 1 BOXTABLET17
25000-135-93Ibuprofen37470 in 1 BAGTABLET374707
25000-135-98Ibuprofen1 in 1 BOXTABLET17
25000-135-98Ibuprofen34065 in 1 BAGTABLET340657

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [MARKSANS PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-135IBUPROFEN TABLET [MARKSANS PHARMA LIMITED]7Current NDC, Legacy NDC, 11 package rows20211230_859d7190-586f-4766-a7e7-9e800a72d58b.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
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
ndc (product): 25000-135

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN859d7190-586f-4766-a7e7-9e800a72d58b7
310965ibuprofen 200 MG Oral TabletSCD859d7190-586f-4766-a7e7-9e800a72d58b7
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY859d7190-586f-4766-a7e7-9e800a72d58b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-135-02250000135021 BOTTLE in 1 CARTON (25000-135-02) / 24 TABLET in 1 BOTTLE1 bottle2019-12-200000-00-00NoNoCurrent
25000-135-032500001350330 TABLET in 1 BOTTLE (25000-135-03) 30 tablet2015-11-060000-00-00NoNoCurrent
25000-135-14250000135141000 TABLET in 1 BOTTLE (25000-135-14) 1000 tablet2015-11-060000-00-00NoNoCurrent
25000-135-30250000135306 BAG in 1 BOX (25000-135-30) / 6500 TABLET in 1 BAG6 bag2015-11-060000-00-00NoNoCurrent
25000-135-7025000013570500 TABLET in 1 BOTTLE (25000-135-70) 500 tablet2015-11-060000-00-00NoNoCurrent
25000-135-93250000135931 BAG in 1 BOX (25000-135-93) / 37470 TABLET in 1 BAG1 bag2015-11-060000-00-00NoNoCurrent
25000-135-98250000135981 BAG in 1 BOX (25000-135-98) / 34065 TABLET in 1 BAG1 bag2015-11-060000-00-00NoNoCurrent