Application 021539

Type: NDA
Sponsor: CUMBERLAND PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETADOTE	ACETYLCYSTEINE	INJECTABLE;INTRAVENOUS	6GM/30ML (200MG/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021539-001	ACETADOTE	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021539-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021539-001	8148356	2026-05-21		Drug product	2012-04-04
N021539-001	9327028	2031-07-21	U-1839		2016-05-18
N021539-001	8722738	2032-04-06	U-1373		2014-05-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N021539-001	D-196	2027-11-26

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021539-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021539-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021539-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021539-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021539-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021539-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021539-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021539-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021539-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021539-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021539-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021539-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021539-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021539-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021539-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021539-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021539-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021539-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021539-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021539-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021539-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021539-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021539-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021539-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021539-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021539-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021539-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021539-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021539-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021539-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021539-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021539-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021539-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021539-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021539-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021539-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021539-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021539-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021539-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021539-001	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 201 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021539-001	8399445	2025-08-24	U-1373		2013-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021539-001	8653061	2025-08-24	U-1373		2014-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021539-001	8399445	2025-08-24	U-1373		2013-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021539-001	8653061	2025-08-24	U-1373		2014-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021539-001	8399445	2025-08-24	U-1373		2013-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021539-001	8653061	2025-08-24	U-1373		2014-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021539-001	8399445	2025-08-24	U-1373		2013-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021539-001	8653061	2025-08-24	U-1373		2014-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021539-001	8399445	2025-08-24	U-1373		2013-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021539-001	8653061	2025-08-24	U-1373		2014-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021539-001	8399445	2025-08-24	U-1373		2013-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021539-001	8653061	2025-08-24	U-1373		2014-02-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021539-001	8399445	2025-08-24	U-1373		2013-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021539-001	8653061	2025-08-24	U-1373		2014-02-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021539-001	8399445	2025-08-24	U-1373		2013-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021539-001	8653061	2025-08-24	U-1373		2014-02-24	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021539-001	D-196	2027-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021539-001	D-196	2027-11-26	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021539-001	D-196	2027-11-26	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acetylcysteine	ACETYLCYSTEINE	Padagis US LLC	9d305722-e74f-4f48-8d2c-0daa99144749	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021539 application number: NDA021539 ndc (product): 0574-0805
ACETADOTE	ACETYLCYSTEINE	Cumberland Pharmaceuticals Inc.	472f158a-5ab9-4308-8e49-1116e6ea3d39	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021539 application number: NDA021539 ndc (product): 66220-207

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-0805	acetylcysteine	Acetylcysteine	Paddock Laboratories, LLC	NDA	Current
0574-0805	acetylcysteine	Acetylcysteine	Padagis US LLC	NDA	Current
0574-0805	acetylcysteine	Acetylcysteine	Paddock Laboratories, LLC	NDA	Current
0574-0805	acetylcysteine	Acetylcysteine	Paddock Laboratories, LLC.	NDA	Current
0574-0815	Acetylcysteine	acetylcysteine	Paddock Laboratories, LLC	NDA	Current
0574-0815	Acetylcysteine	acetylcysteine	Paddock Laboratories, LLC	NDA	Current
0574-0815	Acetylcysteine	acetylcysteine	Paddock Laboratories, LLC	NDA	Current
66220-207	ACETADOTE	Acetylcysteine	Cumberland Pharmaceutical	NDA	Current
66220-207	ACETADOTE	Acetylcysteine	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-207	ACETADOTE	Acetylcysteine	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-207	ACETADOTE	Acetylcysteine	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-207	ACETADOTE	Acetylcysteine	Cumberland Pharmaceuticals Inc.	NDA	Current
66220-207	ACETADOTE	Acetylcysteine	Cumberland Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82934	SUPPL	2025-07-25
82918	SUPPL	2025-07-25
80442	SUPPL	2024-11-29
80436	SUPPL	2024-11-27
68797	SUPPL	2021-09-28
60762	SUPPL	2019-10-31
60749	SUPPL	2019-10-31
46987	SUPPL	2017-01-27
46959	SUPPL	2017-01-24
37182	SUPPL	2016-08-02
5682	SUPPL	2016-08-02
15726	SUPPL	2013-06-11
28061	SUPPL	2013-06-06
5681	SUPPL	2008-12-19
37181	SUPPL	2006-02-22
5680	SUPPL	2006-02-22
42205	ORIG	2004-10-18
37180	SUPPL	2004-05-04
15725	SUPPL	2004-05-04
28060	SUPPL	2004-05-03
28059	SUPPL	2004-04-29
15724	ORIG	2004-02-03
5679	ORIG	2004-02-02