Nabumetone

Product NDC: 0115-1657
11-digit product format: 001151657
Labeler code: 0115
Product ID: 0115-1657_e904ba7b-549f-43cb-aafb-ffc109a4d227
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA075189
Marketing category: ANDA
Marketing start: 2001-08-20
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: 2021-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0115-1657		I	Inactivated by FDA	2026-08-17
excluded package	package	0115-1657	0115-1657-01	I	Inactivated by FDA	2026-08-17
excluded package	package	0115-1657	0115-1657-03	I	Inactivated by FDA	2026-08-17

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-1657-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-1657-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-1657-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0115-1657-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-1657-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0115-1657-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-1657-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0115-1657-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-1657-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0115-1657-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-1657-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0115-1657-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-1657-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0115-1657-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-1657-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0115-1657-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-1657-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0115-1657-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-1657-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-1657-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-1657-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-1657-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-1657-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-1657-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0115-1657-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0115-1657-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0115-1657-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0115-1657-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0115-1657-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0115-1657-01	`1332a3947898…`	`d4bfe170f9cd…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075189-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL			2000-05-26
A075189-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL			2001-09-24

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075189-001	NABUMETONE	500MG	TABLET / ORAL	AB		2000-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075189-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2001-09-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075189-001	NABUMETONE	500MG	TABLET / ORAL			2000-05-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075189-002	NABUMETONE	750MG	TABLET / ORAL			2001-09-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075189-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075189-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075189-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075189-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075189-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075189-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075189-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075189-002	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9d4d18c4-d38e-37e1-df1c-ee38762bf8a5	Product name	4	20251024

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0115-1657-01	2023-01-30	C162847	48780-1	f386c64a-08d1-0266-e053-dadaa90a7c1a	NABUMETONE TABLETS USP Rx Only
0115-1657-03	2023-01-30	C162847	48780-1	f386c64a-08d1-0266-e053-dadaa90a7c1a	NABUMETONE TABLETS USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0115-1657-01	Nabumetone	100 in 1 BOTTLE	TABLET, FILM COATED	100		13
0115-1657-03	Nabumetone	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1657-01	EA - Each	0115-1657	98126b4c-2881-4c6f-9b00-0de8f36b09f3	1	2017-03-06
0115-1657-03	EA - Each	0115-1657	3bd623d2-4397-4397-96ba-aeef267b5888	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1657	NABUMETONE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	13	Legacy NDC, 2 package rows	20201230_7b547af0-7be4-4277-8064-1bf1925154bb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LW0TIW155Z	NABUMETONE	42924-53-8	NABUMETONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311892	nabumetone 500 MG Oral Tablet	PSN	7b547af0-7be4-4277-8064-1bf1925154bb	13
311893	nabumetone 750 MG Oral Tablet	PSN	7b547af0-7be4-4277-8064-1bf1925154bb	13
311892	nabumetone 500 MG Oral Tablet	SCD	7b547af0-7be4-4277-8064-1bf1925154bb	13
311893	nabumetone 750 MG Oral Tablet	SCD	7b547af0-7be4-4277-8064-1bf1925154bb	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1657-01	00115165701	100 TABLET, FILM COATED in 1 BOTTLE (0115-1657-01)	2001-08-20	0000-00-00	No	No	Current
0115-1657-03	00115165703	1000 TABLET, FILM COATED in 1 BOTTLE (0115-1657-03)	2001-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NABUMETONE TABLETS USP Rx Only	Quality Care Products, LLC	2019-05-15	HUMAN PRESCRIPTION DRUG LABEL	1
NABUMETONE TABLETS USP Rx Only	Amneal Pharmaceuticals of New York LLC	2019-04-22	HUMAN PRESCRIPTION DRUG LABEL	13