Ibuprofen

Product NDC
58657-680
Requested package NDC
58657-680-01
11-digit product format
586570680
Labeler code
58657
Product ID
58657-680_9d53122c-b5f8-1472-e053-2a95a90a971c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA202413
Marketing category
ANDA
Marketing start
2017-04-15
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 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
2021-12-31
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 packagepackage58657-68058657-680-01DDiscontinued 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 · 7 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
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58657-68058657-680-01DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58657-68058657-680-01DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58657-68058657-680-01DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58657-68058657-680-01DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58657-68058657-680-01DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58657-68058657-680-01DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58657-68058657-680-01DDiscontinued 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202413-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2016-11-23
A202413-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2016-11-23
A202413-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2016-11-23
A202413-004IBUPROFENIBUPROFEN300MGTABLET / ORAL2024-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202413-001AB
A202413-002AB
A202413-003AB

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 · 135 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05d06236e962d9…

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 UTC2026-02A202413-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202413-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202413-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202413-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202413-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202413-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202413-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202413-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202413-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202413-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202413-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202413-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202413-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202413-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202413-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202413-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202413-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202413-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202413-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202413-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202413-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202413-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202413-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202413-001AB18072bd15b7f6…

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 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENREMEDYREPACK INC.2572ed69-d5a7-4513-a202-aca3230e7ec52026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.656658cc-8cf0-42b6-af4f-4e3ab76486252026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.c0156053-add5-4bd5-b89f-f90df2e73be42026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3a38add6-a114-4e18-836c-3bfc727db2312026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug5302291e-4816-8495-e063-6394a90a9cc02026-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENREMEDYREPACK INC.404df13d-4ada-4324-9eed-e21f5d5043a42026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENST. MARY'S MEDICAL PARK PHARMACY4e67aef4-c3ac-232a-e063-6394a90a3a852026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENBryant Ranch Prepack886c974c-0d32-4a1b-8f54-40c2c12efa452026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.2e0f74a5-b8f3-fc81-e063-6394a90a647a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENProficient Rx LPab2f1a30-611b-41b6-9baf-6a82305da8452026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.4b34b58b-2cf7-9aa8-e063-6294a90a06582026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutions0170876a-d8cd-4a2d-8397-db2acdf72ffb2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.70e191ef-8fad-49eb-9850-fceea119e92f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.b84ea215-e61d-4c00-8a34-d47c4080779b2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENCoupler LLC4831785a-cde2-79a2-e063-6294a90a9a402026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENAiPing Pharmaceutical, Inc.3e131710-2579-446e-8076-f602ecea813f2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENChartwell RX, LLC39f2664f-6c0a-4726-85d7-4227530d4a492025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug44f278ac-6bf9-6aef-e063-6394a90a0bb62025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug44f5743f-8c98-dc4d-e063-6294a90a6dfa2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug44f609dd-c868-493f-e063-6294a90a71382025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-680-01EA - Each58657-68017122841-8e6c-44b3-b449-23c4c706a32112017-05-04
58657-680-50EA - Each58657-680357e6dc7-708d-4c8f-b1ca-1e110035e8aa12017-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-680-0158657068001100 TABLET in 1 BOTTLE (58657-680-01) 100 tablet2017-04-150000-00-00NoNoCurrent