Nabumetone

Product NDC: 35356-687
11-digit product format: 353560687
Labeler code: 35356
Product ID: 35356-687_4c2df86f-d890-4542-afcb-dcea323df11f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Application: ANDA091083
Marketing category: ANDA
Marketing start: 2011-06-13
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	35356-687		D	Discontinued by firm	2026-08-17
excluded package	package	35356-687	35356-687-00	D	Discontinued by firm	2026-08-17
excluded package	package	35356-687	35356-687-14	D	Discontinued by firm	2026-08-17
excluded package	package	35356-687	35356-687-15	D	Discontinued by firm	2026-08-17
excluded package	package	35356-687	35356-687-20	D	Discontinued by firm	2026-08-17
excluded package	package	35356-687	35356-687-30	D	Discontinued by firm	2026-08-17
excluded package	package	35356-687	35356-687-60	D	Discontinued by firm	2026-08-17
excluded package	package	35356-687	35356-687-90	D	Discontinued by firm	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 3 · 152 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	35356-687-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-687-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-687-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-687-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-687-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-687-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-687-15	`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	35356-687-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-687-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-687-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-687-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-687-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-687-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-687-15	`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	35356-687-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-687-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-687-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-687-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-687-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-687-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-687-15	`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	35356-687-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-687-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-687-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-687-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-687-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-687-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-687-15	`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	35356-687-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-687-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-687-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-687-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-687-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-687-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-687-15	`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	35356-687-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-687-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-687-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-687-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-687-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-687-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-687-15	`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	35356-687-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-687-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-687-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-687-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-687-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-687-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-687-15	`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	35356-687-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-687-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-687-14	`ed331223b511…`	`672a5bd82f5f…`

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
A091083-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2011-06-13
A091083-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB		2011-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091083-001	AB
A091083-002	AB

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091083-001	NABUMETONE	500MG	TABLET / ORAL	AB	2011-06-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091083-002	NABUMETONE	750MG	TABLET / ORAL	AB	2011-06-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091083-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091083-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091083-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091083-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091083-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091083-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091083-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091083-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091083-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091083-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091083-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091083-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091083-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091083-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091083-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091083-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091083-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091083-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091083-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091083-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091083-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091083-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091083-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091083-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091083-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091083-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091083-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091083-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091083-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091083-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091083-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091083-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091083-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091083-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091083-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091083-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091083-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091083-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091083-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091083-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
35356-687-00	2025-01-14	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-14	2025-01-14	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-15	2025-01-14	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-20	2025-01-14	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-30	2025-01-14	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-60	2025-01-14	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-90	2025-01-14	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-00	2021-01-29	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-14	2021-01-29	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-15	2021-01-29	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-20	2021-01-29	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-30	2021-01-29	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-60	2021-01-29	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702
35356-687-90	2021-01-29	Nabumetone Tablets, USP Revised: December 2010 Rx only 195702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-687-30	EA - Each	35356-687	64298c31-b71c-4c48-9167-b37b63f98b31	1	2012-07-24
35356-687-60	EA - Each	35356-687	6de212f9-8d66-4afa-afd0-825e6a1e91db	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NABUMETONE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3918

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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Bryant Ranch Prepack	0186328f-3eb7-4407-bf9e-8007d08ebe7b	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083
Nabumetone	NABUMETONE	Bryant Ranch Prepack	dd0d2652-d335-45db-af43-5a2523f7299a	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083
Nabumetone	NABUMETONE	Actavis Pharma, Inc.	53656d70-6572-4669-6465-6c6973555341	2025-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083
Nabumetone	NABUMETONE	Proficient Rx LP	0870c3c9-bfce-4722-8779-8775644196d3	2022-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083
Nabumetone	NABUMETONE	Proficient Rx LP	079a8a9e-6d71-414a-83f3-ef68e323c1fd	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091083 application number: ANDA091083

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nabumetone Tablets, USP Revised: December 2010 Rx only 195702	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	3919