ACETADOTE

Product NDC: 66220-207
11-digit product format: 662200207
Labeler code: 66220
Product ID: 66220-207_f8e9f360-c181-40a1-87d6-dcd9a3205000
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetylcysteine
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Cumberland Pharmaceuticals Inc.
Application: NDA021539
Marketing category: NDA
Marketing start: 2004-01-23
Substance: ACETYLCYSTEINE
Active strength: 200 mg/mL
Pharmacologic classes: Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	66220-207		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66220-207	66220-207-30	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: ACETADOTE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETYLCYSTEINE	200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WYQ7N0BPYC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
465377	Internal RxNorm lookup
582119	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
472f158a-5ab9-4308-8e49-1116e6ea3d39	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7b19f89e-0a13-4d4e-a994-a46d39d008b9	Product name	1	20251120
13c3e0af-2da2-8aec-9e17-1afd680d80c2	Product name	8	20221116
f46c867f-cde5-4f14-a7c1-18ae3a6efd1c	Product name	1	20160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66220-207-30	2023-01-27	C162847	48780-1	e4f33bdf-b22f-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ACETADOTE safely and effectively. See full prescribing information for ACETADOTE. ACETADOTE (acetylcysteine) injection, for intravenous use Initial U.S. Approval: 2004
66220-207-30	2022-07-29	C162847	48780-1	e4f33bdf-b22f-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use ACETADOTE safely and effectively. See full prescribing information for ACETADOTE. ACETADOTE (acetylcysteine) injection, for intravenous use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66220-207-30	ACETADOTE	30 mL in 1 VIAL	INJECTION, SOLUTION	30		17
66220-207-30	ACETADOTE	4 in 1 CARTON	INJECTION, SOLUTION	4		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66220-207-30	ML - Milliliter	66220-207	af63f276-3b51-41cf-9775-31eaa4b563f1	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetylcysteine	ACTIVE INGREDIENT	WYQ7N0BPYC	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5
Acetylcysteine	ACTIVE MOIETY	WYQ7N0BPYC	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5
nitrogen	INACTIVE INGREDIENT	N762921K75	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5
water	INACTIVE INGREDIENT	059QF0KO0R	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66220-207	ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	15	Current NDC, Legacy NDC, 2 package rows	20241207_472f158a-5ab9-4308-8e49-1116e6ea3d39.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 · 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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WYQ7N0BPYC	ACETYLCYSTEINE	616-91-1	ACETYLCYSTEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
582119	Acetadote 6 GM in 30 ML Injection	PSN	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
465377	acetylcysteine 6 GM in 30 ML Injection	PSN	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
582119	30 ML acetylcysteine 200 MG/ML Injection [Acetadote]	SBD	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
465377	30 ML acetylcysteine 200 MG/ML Injection	SCD	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
582119	Acetadote 6 GM per 30 ML Injection	SY	472f158a-5ab9-4308-8e49-1116e6ea3d39	17
465377	acetylcysteine 6 GM per 30 ML Injection	SY	472f158a-5ab9-4308-8e49-1116e6ea3d39	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66220-207-30	66220020730	4 VIAL in 1 CARTON (66220-207-30) / 30 mL in 1 VIAL	4 vial	2004-01-23	0000-00-00	No	No	Current