Application 078420

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NABUMETONE	NABUMETONE	TABLET;ORAL	500MG	No	No
002	NABUMETONE	NABUMETONE	TABLET;ORAL	750MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078420-001	NABUMETONE	NABUMETONE	500MG	TABLET / ORAL	AB		2008-09-24
A078420-002	NABUMETONE	NABUMETONE	750MG	TABLET / ORAL	AB		2008-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078420-001	AB
A078420-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078420-001	NABUMETONE	500MG	TABLET / ORAL	AB	2008-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078420-002	NABUMETONE	750MG	TABLET / ORAL	AB	2008-09-24	`4b0b4de00fa7…`

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
2026-10-15 13:18:30	2026-09	A078420-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A078420-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078420-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078420-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078420-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078420-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078420-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078420-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078420-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078420-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078420-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078420-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078420-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078420-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078420-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078420-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078420-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078420-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078420-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078420-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078420-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078420-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078420-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078420-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078420-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078420-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078420-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078420-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078420-002	AB	1	`4b0b4de00fa7…`

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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nabumetone	NABUMETONE	PD-Rx Pharmaceuticals, Inc.	69620c53-b37a-45b9-b560-221bbcd98fda	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420 ndc (product): 72789-040
NABUMETONE	NABUMETONE	direct rx	a8600b12-f180-0b27-e053-2995a90acbd9	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	ScieGen Pharmaceuticals Inc	80c6888d-03b4-44f3-b94d-bcf5154ceae5	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Advanced Rx of Tennessee, LLC	af9994ac-6687-2df2-e053-2995a90a959a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420 ndc (product): 80425-0054
Nabumetone	NABUMETONE	Advanced Rx Pharmacy of Tennessee, LLC	b43db4aa-6013-3942-e053-2a95a90a5189	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420 ndc (product): 80425-0104
Nabumetone	NABUMETONE	Quality Care Products, LLC	da259c7c-6f1e-403c-b42b-596d53b61fe5	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Quality Care Products, LLC	065fdacc-739e-4b46-bebc-044b5c11bbbb	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	A-S Medication Solutions	26037234-daca-4f1a-a7a7-0871f77283f0	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	A-S Medication Solutions	d997d125-dfc5-4cc5-b7a6-03f5a7248d14	2024-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Westminster Pharmaceuticals, LLC	264df44a-e294-4d9b-9113-92859cb08c20	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Bryant Ranch Prepack	62f2e0bf-e5c8-480c-ac5e-401ced3bbc67	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Proficient Rx LP	7a1643bf-6627-4b12-8246-6acc40517cf2	2022-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Proficient Rx LP	f4392863-ed3f-4fbd-8260-49827609aa2e	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420
Nabumetone	NABUMETONE	Asclemed USA, Inc.	04a71deb-2c9d-436c-a574-e5991b6a5248	2022-03-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078420 application number: ANDA078420 ndc (product): 76420-210

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 95 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-040	Nabumetone	Nabumetone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76420-210	Nabumetone	Nabumetone	Asclemed USA, Inc.	ANDA	Current
80425-0054	Relafen	Nabumetone 500mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0054	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0054	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0054	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0104	Relafen	Nabumetone 750mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0104	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0104	Nabumetone	Nabumetone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current