Nabumetone

Product NDC
55700-845
Requested package NDC
55700-845-30
11-digit product format
557000845
Labeler code
55700
Product ID
55700-845_273dcba6-29a0-47f9-83b4-04d1e692232e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nabumetone
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078420
Marketing category
ANDA
Marketing start
2020-02-28
Marketing end
2027-03-31
Substance
NABUMETONE
Active strength
500 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-84555700-845-30DDiscontinued 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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
A078420-001NABUMETONENABUMETONE500MGTABLET / ORALAB2008-09-24
A078420-002NABUMETONENABUMETONE750MGTABLET / ORALAB2008-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078420-001AB
A078420-002AB

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 06:07:402026-07A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078420-001NABUMETONE500MGTABLET / ORALAB2008-09-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078420-002NABUMETONE750MGTABLET / ORALAB2008-09-24bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078420-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078420-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078420-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078420-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078420-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078420-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078420-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078420-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078420-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078420-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078420-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078420-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078420-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078420-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078420-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078420-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078420-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078420-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078420-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078420-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078420-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078420-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078420-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078420-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078420-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078420-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078420-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078420-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078420-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078420-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078420-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078420-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078420-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078420-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078420-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078420-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078420-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078420-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078420-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078420-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Nabumetone

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NABUMETONE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LW0TIW155ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311892Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
065fdacc-739e-4b46-bebc-044b5c11bbbbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5Product name420251024

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-845-30Nabumetone30 in 1 BOTTLETABLET306
55700-845-60Nabumetone60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-845-30EA - Each55700-84565a014e7-fe22-4401-ae39-c9135f31eaee12020-04-20
55700-845-60EA - Each55700-8452f762786-ce06-4293-b4e2-4549cfd1c20812020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-845NABUMETONE TABLET [QUALITY CARE PRODUCTS, LLC]6Current NDC, Legacy NDC, 2 package rows20241220_065fdacc-739e-4b46-bebc-044b5c11bbbb.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 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NabumetoneNABUMETONEPreferred Pharmaceuticals, Inc.95769e02-fa4a-4389-a2fa-3146eae025262026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEPreferred Pharmaceuticals Inc.455c9992-39a0-4353-a121-57e700c779422026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONESt. Mary's Medical Park Pharmacy95aa8124-08fe-ff2f-e053-2a95a90a3c8f2026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEREMEDYREPACK INC.311ae656-55d2-4116-a1bd-6f4a4ce701852026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONESt. Mary's Medical Park Pharmacy94930125-b792-579e-e053-2995a90ab6f92026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEREMEDYREPACK INC.6106afa3-e138-4b4d-8c13-992bf50620972026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONENorthwind Health Company, LLCd9ca2484-7293-7db6-e053-2995a90a0f132026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONENorthwind Health Company, LLCda34003b-81a4-2efd-e053-2995a90a961c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONERedpharm Drug3745775e-e11a-01db-e063-6294a90a9b522025-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.75c51686-9c5e-4c13-acf4-2d04502eedda2025-12-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack583602ff-dbbe-4369-afa9-b917734ac9b12025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepackb2a41c0b-e2ad-4e14-a2f7-2049c12c35da2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepackad9f2a34-6244-49b7-98ee-af18cb55693c2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack06f73fa8-7a8f-4160-939e-a25980a119062025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack5a66c21f-4f06-4fb8-98fa-e81949586afd2025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack419c597f-6a6f-4420-b240-7dc4c223387e2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepacka4553637-498e-491a-982a-cff81b43aa6c2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack5ba602e9-846e-42b3-9ea6-fb461a9489472025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEBryant Ranch Prepack0be7ee60-2706-43ed-98ec-b89cd4e2b57c2025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420
NabumetoneNABUMETONEPD-Rx Pharmaceuticals, Inc.69620c53-b37a-45b9-b560-221bbcd98fda2025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078420
application number: ANDA078420

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311892nabumetone 500 MG Oral TabletPSN065fdacc-739e-4b46-bebc-044b5c11bbbb6
311892nabumetone 500 MG Oral TabletSCD065fdacc-739e-4b46-bebc-044b5c11bbbb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-845-305570008453030 TABLET in 1 BOTTLE (55700-845-30) 30 tablet2020-02-280000-00-00NoNoCurrent