FDA.reportPublic FDA data

ibuprofen

Product NDC
71335-2068
11-digit product format
713352068
Labeler code
71335
Product ID
71335-2068_2c91e959-d2c7-48ce-a4a5-6c540fb90895
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA072096
Marketing category
ANDA
Marketing start
1994-08-16
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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08c2088c7a36db…
2026-09-14 22:38:342026-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0884e616aacf4f…
2026-08-18 06:07:402026-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
230fd746-92e0-40b6-9a90-595812bd8a18Available 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
71335-2068-0ibuprofen90 in 1 BOTTLETABLET, FILM COATED90102
71335-2068-1ibuprofen20 in 1 BOTTLETABLET, FILM COATED20102
71335-2068-2ibuprofen15 in 1 BOTTLETABLET, FILM COATED15102
71335-2068-3ibuprofen30 in 1 BOTTLETABLET, FILM COATED30102
71335-2068-4ibuprofen100 in 1 BOTTLETABLET, FILM COATED100102
71335-2068-5ibuprofen60 in 1 BOTTLETABLET, FILM COATED60102
71335-2068-6ibuprofen50 in 1 BOTTLETABLET, FILM COATED50102
71335-2068-7ibuprofen40 in 1 BOTTLETABLET, FILM COATED40102
71335-2068-8ibuprofen10 in 1 BOTTLETABLET, FILM COATED10102
71335-2068-9ibuprofen56 in 1 BOTTLETABLET, FILM COATED56102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2068IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20231026_230fd746-92e0-40b6-9a90-595812bd8a18.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 2 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENWalgreen Company37c9b887-190a-4daf-8199-f406913132f02025-09-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLCcfa8578c-2bcc-4aa7-bb8c-0d0e193020ed2025-08-28WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENBryant Ranch Prepack230fd746-92e0-40b6-9a90-595812bd8a182025-08-20WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 71335-2068
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader63b8d389-7feb-41d2-8970-b7d5660ccb4a2025-08-14WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Topcare IbuprofenIBUPROFENTopco Associates LLC8be375b0-c729-49de-abc5-2e7d37144b892025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen08d9477e-3033-4b74-8f81-934f39e37e552025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI9bf3546a-9f94-47b5-9b01-aed93e69d5aa2025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENCVS Pharmacye655bd64-dd82-46d8-87cc-2674beaffe202025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMajor Pharmaceuticals03993008-7bd2-465f-b5a9-1cbc3c1fff022025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENPublix Super Markets Inc032decc5-9f7a-4f12-8ca4-a95a79a426c62025-06-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
care one ibuprofenIBUPROFENAmerican Sales Company006adf23-21ab-4a4e-aae9-c4e5877771652025-06-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMeijer Distribution Inc66b19ed1-6cf9-4705-82cd-02f23c6379e72025-05-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
kirkland signature ibuprofenIBUPROFENCostco Wholesale Company65d8d650-9afc-44f7-9409-a3aa3014d4ab2025-04-24WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENA-S Medication Solutions504c7e5d-e721-4df8-865b-8ea17559831d2025-04-24WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
up and up ibuprofenIBUPROFENTarget Corporation2919fe8b-9c76-4ef6-851e-3247782cef442025-04-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIe18f4ce6-d7d3-4b53-b87a-5900ac3397f12025-04-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
TopCare IbuprofenIBUPROFENTopco Associates LLC66097f19-227c-4f9c-a7f3-ab8476e1bb6e2025-04-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENMajor Pharmaceuticals14f43c32-0895-4ef2-aa54-52b952d058fd2025-04-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Equate IbuprofenIBUPROFENWal-Mart Stores Inc01e9b5b9-cb49-4bfa-9a90-ece8940bf7682025-02-11WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergena07c45b4-dc98-4b73-a1c1-84b108cf37e92025-01-03WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN230fd746-92e0-40b6-9a90-595812bd8a18102
310965ibuprofen 200 MG Oral TabletSCD230fd746-92e0-40b6-9a90-595812bd8a18102
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY230fd746-92e0-40b6-9a90-595812bd8a18102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2068-07133520680090 TABLET, FILM COATED in 1 BOTTLE (71335-2068-0) 2022-03-290000-00-00NoNoCurrent
71335-2068-17133520680120 TABLET, FILM COATED in 1 BOTTLE (71335-2068-1) 2022-03-290000-00-00NoNoCurrent
71335-2068-27133520680215 TABLET, FILM COATED in 1 BOTTLE (71335-2068-2) 2022-03-290000-00-00NoNoCurrent
71335-2068-37133520680330 TABLET, FILM COATED in 1 BOTTLE (71335-2068-3) 2022-03-290000-00-00NoNoCurrent
71335-2068-471335206804100 TABLET, FILM COATED in 1 BOTTLE (71335-2068-4) 2022-03-290000-00-00NoNoCurrent
71335-2068-57133520680560 TABLET, FILM COATED in 1 BOTTLE (71335-2068-5) 2022-03-290000-00-00NoNoCurrent
71335-2068-67133520680650 TABLET, FILM COATED in 1 BOTTLE (71335-2068-6) 2022-03-290000-00-00NoNoCurrent
71335-2068-77133520680740 TABLET, FILM COATED in 1 BOTTLE (71335-2068-7) 2022-03-290000-00-00NoNoCurrent
71335-2068-87133520680810 TABLET, FILM COATED in 1 BOTTLE (71335-2068-8) 2022-03-290000-00-00NoNoCurrent
71335-2068-97133520680956 TABLET, FILM COATED in 1 BOTTLE (71335-2068-9) 2022-03-290000-00-00NoNoCurrent