Ibuprofen

Product NDC
63739-134
11-digit product format
637390134
Labeler code
63739
Product ID
63739-134_3d055404-f915-40a4-8f8f-7bc72ee2ce02
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
McKesson Packaging Services Business Unit of McKesson Corporation
Application
ANDA071163
Marketing category
ANDA
Marketing start
2005-01-10
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63739-134DDiscontinued by firm2026-10-12
excluded packagepackage63739-13463739-134-01DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63739-134-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63739-134-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63739-134-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63739-134-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63739-134-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63739-134-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63739-134-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63739-134-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63739-134-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63739-134-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63739-134-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63739-134-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63739-134-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63739-134-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63739-134-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A071163-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1986-07-15

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-1584e616aacf4f…
2026-08-18 06:07:402026-07A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-153f01610625f2…
2019-09-15 20:21 UTC2019-09A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071163-001IBUPROFEN200MGTABLET / ORAL1986-07-15f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-134-012021-07-16C16284748780-19d75b9d0-e05f-f424-e053-dadaa90a57ceDrug Facts
63739-134-012020-01-31C16284748780-19d75b9d0-e05f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-134-01EA - Each63739-134d8c6cbb0-2da8-4131-ae63-01fc9fe4f1b612012-07-24

DailyMed Socrata Ingredients#