ibuprofen

Product NDC
0904-6747
11-digit product format
009046747
Labeler code
0904
Product ID
0904-6747_dddfc800-cfd3-42d4-82e1-04414822fbfc
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA072096
Marketing category
ANDA
Marketing start
2018-09-20
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
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

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 UTC2026-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08cb3db0bc1861…

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
14f43c32-0895-4ef2-aa54-52b952d058fdAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6747-24ibuprofen24 in 1 BOTTLETABLET, FILM COATED245
0904-6747-24ibuprofen1 in 1 CARTONTABLET, FILM COATED15
0904-6747-40ibuprofen500 in 1 BOTTLETABLET, FILM COATED5005
0904-6747-51ibuprofen1 in 1 CARTONTABLET, FILM COATED15
0904-6747-51ibuprofen50 in 1 BOTTLETABLET, FILM COATED505
0904-6747-59ibuprofen100 in 1 BOTTLETABLET, FILM COATED1005
0904-6747-59ibuprofen1 in 1 CARTONTABLET, FILM COATED15
0904-6747-70ibuprofen1 in 1 CARTONTABLET, FILM COATED15
0904-6747-70ibuprofen250 in 1 BOTTLETABLET, FILM COATED2505
0904-6747-80ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6747-24EA - Each0904-67479e7eaa4f-cbdc-4368-8d75-7b4cbc1cc0ec12019-07-02
0904-6747-40EA - Each0904-6747f34c2638-7fab-4b82-a2a3-f0cb6ef07d3612019-07-02
0904-6747-51EA - Each0904-6747ba8c2cec-d246-4677-82d0-66ba6a09374812019-04-11
0904-6747-59EA - Each0904-67478bd44971-5c1b-431e-89db-5a4984d3dcac12019-09-05
0904-6747-70EA - Each0904-6747a8462561-a70c-4156-987e-8d0147e6aba212019-07-02
0904-6747-80EA - Each0904-6747b1ae7f17-0c46-4608-a842-f574b8f6e24f12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6747IBUPROFEN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 10 package rows20250410_14f43c32-0895-4ef2-aa54-52b952d058fd.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 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENUnit Dose Solutions, Inc.551535ce-eab0-bb13-e063-6294a90a20702026-06-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Berkley and Jensen IbuprofenIBUPROFENBJWCcda57e42-6106-46ee-82d1-479a692ee5bb2026-05-21WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen085dcc1a-e4b0-4d08-9476-72275382d1a12026-05-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.f1a03b1f-2d87-43cc-b256-bd296ccd09f22026-05-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENKroger Company6307485a-8be6-40ee-899b-00eb3ee8ce612026-05-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderd673266c-3d2b-479f-9b53-cdd1b86513932026-02-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc5233c409-3743-4312-9f75-14ded6755b5c2026-02-02WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENCVS Pharmacyace493e6-91bc-41aa-8e5c-5bc14981de912026-01-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNorthwind Health Company, LLCda6c2802-5d15-dbcb-e053-2a95a90a25612026-01-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENL. Perrigo Company70d0a429-27c1-43a5-b2ea-a9919e0910f82025-12-22WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.96bff700-bca3-4b94-b8a2-379102721db82025-12-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.c447fc6b-e9ef-447a-9609-5f893e18dfa72025-11-17WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
GOODNOW PAIN RELIEFIBUPROFENGobrands, Inc0759085d-6ac3-446b-ac2c-8dc30e32e1d12025-11-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN22cb2ccc-ba4d-4069-8334-f886f0e3e802103
310965ibuprofen 200 MG Oral TabletSCD22cb2ccc-ba4d-4069-8334-f886f0e3e802103
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY22cb2ccc-ba4d-4069-8334-f886f0e3e802103
310965ibuprofen 200 MG Oral TabletPSN96bff700-bca3-4b94-b8a2-379102721db810
310965ibuprofen 200 MG Oral TabletSCD96bff700-bca3-4b94-b8a2-379102721db810
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY96bff700-bca3-4b94-b8a2-379102721db810
310965ibuprofen 200 MG Oral TabletPSN504c7e5d-e721-4df8-865b-8ea17559831d9
310965ibuprofen 200 MG Oral TabletSCD504c7e5d-e721-4df8-865b-8ea17559831d9
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY504c7e5d-e721-4df8-865b-8ea17559831d9
310965ibuprofen 200 MG Oral TabletPSN14f43c32-0895-4ef2-aa54-52b952d058fd5
310965ibuprofen 200 MG Oral TabletSCD14f43c32-0895-4ef2-aa54-52b952d058fd5
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY14f43c32-0895-4ef2-aa54-52b952d058fd5
310965ibuprofen 200 MG Oral TabletPSN798d33b0-5d7a-4445-8a51-2a3d336f744a4
310965ibuprofen 200 MG Oral TabletPSNda6c2802-5d15-dbcb-e053-2a95a90a25614
310965ibuprofen 200 MG Oral TabletPSNcadceab8-7f83-4698-e053-2a95a90ae3c54
310965ibuprofen 200 MG Oral TabletSCDda6c2802-5d15-dbcb-e053-2a95a90a25614
310965ibuprofen 200 MG Oral TabletSCD798d33b0-5d7a-4445-8a51-2a3d336f744a4
310965ibuprofen 200 MG Oral TabletSCDcadceab8-7f83-4698-e053-2a95a90ae3c54
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYda6c2802-5d15-dbcb-e053-2a95a90a25614
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY798d33b0-5d7a-4445-8a51-2a3d336f744a4
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYcadceab8-7f83-4698-e053-2a95a90ae3c54
310965ibuprofen 200 MG Oral TabletPSNec578861-5a50-5362-e053-2995a90ab54a2
310965ibuprofen 200 MG Oral TabletSCDec578861-5a50-5362-e053-2995a90ab54a2
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYec578861-5a50-5362-e053-2995a90ab54a2
310965ibuprofen 200 MG Oral TabletPSN463ea713-6b27-b00b-e063-6394a90a86461
310965ibuprofen 200 MG Oral TabletSCD463ea713-6b27-b00b-e063-6394a90a86461
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY463ea713-6b27-b00b-e063-6394a90a86461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6747-24009046747241 BOTTLE in 1 CARTON (0904-6747-24) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-09-200000-00-00NoNoCurrent
0904-6747-4000904674740500 TABLET, FILM COATED in 1 BOTTLE (0904-6747-40) 2018-09-200000-00-00NoNoCurrent
0904-6747-51009046747511 BOTTLE in 1 CARTON (0904-6747-51) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-09-200000-00-00NoNoCurrent
0904-6747-59009046747591 BOTTLE in 1 CARTON (0904-6747-59) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-09-200000-00-00NoNoCurrent
0904-6747-70009046747701 BOTTLE in 1 CARTON (0904-6747-70) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-09-200000-00-00NoNoCurrent
0904-6747-80009046747801000 TABLET, FILM COATED in 1 BOTTLE (0904-6747-80) 2018-09-200000-00-00NoNoCurrent