NABUMETONE

Product NDC: 61919-668
11-digit product format: 619190668
Labeler code: 61919
Product ID: 61919-668_83872091-eaeb-d369-e053-2991aa0a998e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NABUMETONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA078671
Marketing category: ANDA
Marketing start: 2016-12-22
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-668		I	Inactivated by FDA	2026-08-17
excluded product	product	61919-668		D	Discontinued by firm	2026-08-17
excluded package	package	61919-668	61919-668-60	I	Inactivated by FDA	2026-08-17
excluded package	package	61919-668	61919-668-90	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 1 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-668-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-668-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-668-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-668-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-668-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-668-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-668-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-668-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-668-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-668-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-668-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-668-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-668-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-668-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-668-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-668-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-668-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-668-90	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-668-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-668-90	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-668-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-668-90	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-668-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-668-90	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-668-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-668-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-668-60	I	Inactivated by FDA	`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
A078671-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07
A078671-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078671-001	AB
A078671-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB		2008-03-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078671-001	NABUMETONE	500MG	TABLET / ORAL	AB		2008-03-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078671-002	NABUMETONE	750MG	TABLET / ORAL	AB	RS	2008-03-07	`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	A078671-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078671-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078671-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078671-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078671-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078671-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078671-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078671-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078671-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078671-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078671-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078671-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078671-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078671-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078671-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078671-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078671-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078671-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078671-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078671-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078671-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078671-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078671-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078671-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078671-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078671-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078671-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078671-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078671-002	AB	1	`bb7c543d1eb4…`

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
61919-668-60	2024-01-30	C162847	48780-1	1030e365-633b-111a-e063-dadaa90a10e2	NABUMETONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-668-60	NABUMETONE	60 in 1 BOTTLE	TABLET, FILM COATED	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-668-30	EA - Each	61919-668	24d5ad7a-494a-4173-b021-4abb5fa477be	1	2019-11-12
61919-668-60	EA - Each	61919-668	47eb06ee-eec2-4322-832c-f8a0e437baa1	1	2018-06-11
61919-668-90	EA - Each	61919-668	d44441e4-b04d-4e1e-97f5-b16722f76cb6	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-668	NABUMETONE TABLET, FILM COATED NABUMETONE TABLET [DIRECT RX]	2	Legacy NDC, 1 package rows	20190312_4445f9d9-4e89-5d88-e054-00144ff8d46c.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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	Northwind Health Company, LLC	b088f564-43ff-8007-e053-2995a90ab012	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	American Health Packaging	0653b873-b74b-4ec6-b112-675760703d91	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	8f3c1b1d-2765-4cb5-92df-044b99339c92	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	Exelan Pharmaceuticals Inc.	16e76e29-9315-40c0-b1d6-8d91961063cf	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	Cipla USA Inc.	85954380-a520-46d7-89ac-e4b19d6e00a1	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671
Nabumetone	NABUMETONE	Advanced Rx of Tennessee, LLC	af9969df-ce14-c0bc-e053-2995a90a3f59	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078671 application number: ANDA078671

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	4445f9d9-4e89-5d88-e054-00144ff8d46c	2
311892	nabumetone 500 MG Oral Tablet	SCD	4445f9d9-4e89-5d88-e054-00144ff8d46c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-668-30	61919066830	30 TABLET, FILM COATED in 1 BOTTLE (61919-668-30)	2019-08-12	0000-00-00	No	No	Current
61919-668-60	61919066860	60 TABLET, FILM COATED in 1 BOTTLE (61919-668-60)	2016-12-22	0000-00-00	No	No	Current
61919-668-90	61919066890	90 TABLET, FILM COATED in 1 BOTTLE (61919-668-90)	2019-08-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NABUMETONE	Direct_Rx	2019-10-14	HUMAN PRESCRIPTION DRUG LABEL	2
NABUMETONE	DIRECT RX	2019-03-07	HUMAN PRESCRIPTION DRUG LABEL	2