Nabumetone

Product NDC
55700-752
11-digit product format
557000752
Labeler code
55700
Product ID
55700-752_f72475b1-c89c-43a6-9cf3-ac19cac759d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA075189
Marketing category
ANDA
Marketing start
2019-05-10
Marketing end
0000-00-00
Substance
NABUMETONE
Active strength
500 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#

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-752DDiscontinued by firm2026-08-17
excluded packagepackage55700-75255700-752-30DDiscontinued by firm2026-08-17
excluded packagepackage55700-75255700-752-60DDiscontinued by firm2026-08-17

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 · 57 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 packagepackage55700-752-30DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-752-60DDiscontinued 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 packagepackage55700-752-30DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-752-60DDiscontinued 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 packagepackage55700-752-30DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-752-60DDiscontinued 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 packagepackage55700-752-30DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-752-60DDiscontinued 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 packagepackage55700-752-30DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-752-60DDiscontinued 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 packagepackage55700-752-30DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-752-60DDiscontinued 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 packagepackage55700-752-30DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-752-60DDiscontinued 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 packagepackage55700-752-30DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-752-60DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-752-60IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-752-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-752-60IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-752-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-752-60IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-752-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-752-60IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-752-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-752-60IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55700-752-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-752-60IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55700-752-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-752-60IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55700-752-30IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55700-752-60IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55700-752-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55700-752-60IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55700-752-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55700-752-60IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55700-752-30IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55700-752-60IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55700-752-30IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075189-001NABUMETONENABUMETONE500MGTABLET / ORAL2000-05-26
A075189-002NABUMETONENABUMETONE750MGTABLET / ORAL2001-09-24

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075189-001NABUMETONE500MGTABLET / ORAL2000-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075189-002NABUMETONE750MGTABLET / ORAL2001-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075189-001NABUMETONE500MGTABLET / ORAL2000-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075189-002NABUMETONE750MGTABLET / ORAL2001-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075189-001NABUMETONE500MGTABLET / ORAL2000-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075189-002NABUMETONE750MGTABLET / ORAL2001-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075189-001NABUMETONE500MGTABLET / ORAL2000-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075189-002NABUMETONE750MGTABLET / ORAL2001-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075189-001NABUMETONE500MGTABLET / ORAL2000-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075189-002NABUMETONE750MGTABLET / ORAL2001-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075189-001NABUMETONE500MGTABLET / ORAL2000-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075189-002NABUMETONE750MGTABLET / ORAL2001-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075189-001NABUMETONE500MGTABLET / ORAL2000-05-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075189-002NABUMETONE750MGTABLET / ORAL2001-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075189-001NABUMETONE500MGTABLET / ORAL2000-05-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075189-002NABUMETONE750MGTABLET / ORAL2001-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075189-001NABUMETONE500MGTABLET / ORAL2000-05-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075189-002NABUMETONE750MGTABLET / ORAL2001-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075189-001NABUMETONE500MGTABLET / ORAL2000-05-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075189-002NABUMETONE750MGTABLET / ORAL2001-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075189-001NABUMETONE500MGTABLET / ORAL2000-05-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075189-002NABUMETONE750MGTABLET / ORAL2001-09-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075189-001NABUMETONE500MGTABLET / ORALAB2000-05-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075189-002NABUMETONE750MGTABLET / ORALABRS2001-09-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075189-001NABUMETONE500MGTABLET / ORAL2000-05-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075189-002NABUMETONE750MGTABLET / ORAL2001-09-24bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A075189-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075189-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A075189-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A075189-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075189-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075189-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075189-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075189-002AB1ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-752-30EA - Each55700-752b6edc55f-21bb-4902-a22e-8bee7bea6f2b12019-06-19
55700-752-60EA - Each55700-752c3086168-a4c7-428f-9c67-38e1f11e406812019-06-19