National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2013-02-13
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 03:20:29

Label at a glance#

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66220-207	66220-207-30

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

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 · 44 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
2026-10-15 13:18:30	2026-09	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021539-001	ACETADOTE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2004-01-23	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	N021539-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021539-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021539-001	AP	1	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021539-001	8148356	2026-05-21		Drug product	2012-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021539-001	9327028	2031-07-21	U-1839		2016-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021539-001	8722738	2032-04-06	U-1373		2014-05-27	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N021539-001	D-196	2027-11-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021539-001	D-196	2027-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021539-001	D-196	2027-11-26	`caaa826d4ba7…`
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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETADOTE	ACETYLCYSTEINE	Cumberland Pharmaceuticals Inc.	472f158a-5ab9-4308-8e49-1116e6ea3d39	2025-04-30	Warnings, Adverse reactions	Exact identifier ndc (package): 66220-207-30 ndc11 (package): 66220020730

Reported adverse events (FAERS/openFDA)#

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