NABUMETONE

Product NDC: 61919-159
Requested package NDC: 61919-159-90
11-digit product format: 619190159
Labeler code: 61919
Product ID: 61919-159_9ca996d4-3b69-05db-e053-2995a90a9b81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NABUMETONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA075189
Marketing category: ANDA
Marketing start: 2016-03-03
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-159	61919-159-90	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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61919-159-90	2023-01-30	d6a99b39-a086-a426-e053-dadaa90af4c2	NABUMETONE 500mg
61919-159-90	2022-01-28	d6a99b39-a086-a426-e053-dadaa90af4c2	NABUMETONE 500mg
61919-159-30	2020-01-31	9d75b9cf-f560-f424-e053-dadaa90a57ce	NABUMETONE
61919-159-60	2020-01-31	9d75b9cf-f560-f424-e053-dadaa90a57ce	NABUMETONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-159-90	NABUMETONE	90 in 1 BOTTLE	TABLET, FILM COATED	90	3
61919-159-30	NABUMETONE	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
61919-159-60	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
61919-159-60	EA - Each	61919-159	37591a8f-f4fc-498f-94cc-ab3983bf9ac8	1	2014-05-02
61919-159-90	EA - Each	61919-159	69c3a1b0-de69-4792-8448-c51d1c374e02	1	2018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NABUMETONE	ACTIVE INGREDIENT	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
NABUMETONE	ACTIVE MOIETY	LW0TIW155Z	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-159	NABUMETONE TABLET, FILM COATED [DIRECT RX]	3	Legacy NDC, 1 package rows	20200131_2d8f206e-0853-43ca-e054-00144ff8d46c.zip
61919-159	NABUMETONE TABLET, FILM COATED [DIRECT RX]	2	Legacy NDC, 2 package rows	20150829_3cbe54ab-137b-4a1d-8490-d9e826cccbfc.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	2d8f206e-0853-43ca-e054-00144ff8d46c	3
311892	nabumetone 500 MG Oral Tablet	SCD	2d8f206e-0853-43ca-e054-00144ff8d46c	3
311892	nabumetone 500 MG Oral Tablet	PSN	3cbe54ab-137b-4a1d-8490-d9e826cccbfc	2
311893	nabumetone 750 MG Oral Tablet	PSN	3cbe54ab-137b-4a1d-8490-d9e826cccbfc	2
311892	nabumetone 500 MG Oral Tablet	SCD	3cbe54ab-137b-4a1d-8490-d9e826cccbfc	2
311893	nabumetone 750 MG Oral Tablet	SCD	3cbe54ab-137b-4a1d-8490-d9e826cccbfc	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-159-90	61919015990	90 TABLET, FILM COATED in 1 BOTTLE (61919-159-90)	2016-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NABUMETONE 500mg	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
NABUMETONE	Direct Rx	2015-08-19	HUMAN PRESCRIPTION DRUG LABEL	2