Ibuprofen

Product NDC
60760-374
Requested package NDC
60760-374-28
11-digit product format
607600374
Labeler code
60760
Product ID
60760-374_7b32cc4d-ab0a-0d0b-e053-2a91aa0a0650
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA091625
Marketing category
ANDA
Marketing start
2018-03-12
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60760-37460760-374-28DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 11 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60760-37460760-374-28DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091625-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2015-09-15
A091625-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2015-09-15
A091625-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2015-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091625-001AB
A091625-002AB
A091625-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-002IBUPROFEN600MGTABLET / ORALAB2015-09-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-003IBUPROFEN800MGTABLET / ORALAB2015-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091625-001IBUPROFEN400MGTABLET / ORALAB2015-09-158072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091625-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091625-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091625-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091625-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091625-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091625-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091625-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091625-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091625-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091625-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091625-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091625-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091625-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091625-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091625-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091625-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091625-001AB18072bd15b7f6…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.d3a7ebef-f7ab-4b34-b62e-278a8deabf782026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.b81c6495-8b30-41ef-8a0f-4cbfd87f1eb42026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d82026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.57a1bf99-5aaf-432d-86ba-5f0e7cfab1a02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENBryant Ranch Prepackf1c88d74-09b0-4b14-baea-106fbbbc54bf2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.b6a6c940-daf6-4e0e-aefb-35cce87a9a552026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.421156d2-85dc-4680-b2b4-d15b67539e872026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.20078671-536f-4b0b-a079-f90ac186a6702026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.1e6f3ce7-e8a3-40e8-8437-523ef5277b2e2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENUnit Dose Solutions, Inc.5515661b-6373-2191-e063-6294a90a17e02026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutionsb40f39e4-a37c-4039-ae37-210c1c3c62352026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutions51de1183-d226-4869-a00a-f6c74e126a392026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENA-S Medication Solutions25a94943-9acc-49c8-a4da-7e07bb2c35eb2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENNorthwind Health Company, LLCab80abe6-f7db-479b-e053-2a95a90a90e32026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENAscend Laboratories, LLC9ce036ef-a22d-4fca-9a62-1b10978f7b262026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENQPharma Incfd8b82a7-96fe-8bf5-e053-6394a90a39352026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENGranules Pharmaceuticals Inc.4aefcb3a-5dc8-b88e-e063-6294a90ac0442026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IBUPROFENIBUOROFENDirect_Rx90b8b80e-ab30-3590-e053-2a95a90a70ef2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625
IbuprofenIBUPROFENLegacy Pharmaceutical Packaging, LLC5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091625
application number: ANDA091625

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-374-20EA - Each60760-37417716f15-efa8-4821-87a5-fef40615ec6812018-04-19
60760-374-28EA - Each60760-374df82fd2d-ce79-4726-acc9-596d31eec5af12018-05-09
60760-374-30EA - Each60760-374b09503db-8d36-4658-a2a8-e47d9ee44b8912018-04-19
60760-374-40EA - Each60760-37466d2863c-169f-4b73-adcd-17924eb94f3a12018-06-11
60760-374-60EA - Each60760-374bdc024cc-94be-47cf-a471-19b23b0d209012019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-374-286076003742828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-374-28) 2018-04-090000-00-00NoNoCurrent