Acetylcysteine

Product NDC: 0517-7630
11-digit product format: 005177630
Labeler code: 0517
Product ID: 0517-7630_d8c54054-153b-4e3a-9446-700b6f80bd6e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetylcysteine
Dosage form: INHALANT
Route: RESPIRATORY (INHALATION)
Labeler: American Regent, Inc.
Application: ANDA072547
Marketing category: ANDA
Marketing start: 1995-10-01
Marketing end: 0000-00-00
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: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0517-7630		D	Discontinued by firm		2026-08-17
excluded package	package	0517-7630	0517-7630-03	D	Discontinued by firm		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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0517-7630-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0517-7630-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0517-7630-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0517-7630-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0517-7630-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0517-7630-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0517-7630-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0517-7630-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0517-7630-03	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A072547-001	ACETYLCYSTEINE	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072547-001	AN

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 · 42 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	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072547-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	RS	1995-07-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A072547-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072547-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072547-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072547-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072547-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072547-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072547-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072547-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072547-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072547-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072547-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072547-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072547-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072547-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072547-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072547-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072547-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072547-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072547-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072547-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072547-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072547-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072547-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072547-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072547-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072547-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072547-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072547-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072547-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072547-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072547-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072547-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072547-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072547-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072547-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072547-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072547-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072547-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072547-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072547-001	AN	1	`e64feba35796…`

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0517-7630-03	Acetylcysteine	3 in 1 BOX	INHALANT	3		11
0517-7630-03	Acetylcysteine	30 mL in 1 VIAL, GLASS	INHALANT	30		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-7630-03	ML - Milliliter	0517-7630	77d32fc9-e79f-4f53-b1b2-2d39a66c5e91	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETYLCYSTEINE	ACTIVE INGREDIENT	WYQ7N0BPYC	ACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]	7
ACETYLCYSTEINE	ACTIVE MOIETY	WYQ7N0BPYC	ACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0517-7630	ACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]	11	Legacy NDC, 2 package rows	20241219_f56b4087-db48-4fd7-84ec-9c927962b805.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	Cardinal Health 107, LLC	c90fca12-12fb-4cf6-bd6f-83bc0d95df81	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072547 application number: ANDA072547
Acetylcysteine	ACETYLCYSTEINE	American Regent, Inc.	f56b4087-db48-4fd7-84ec-9c927962b805	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072547 application number: ANDA072547 ndc (product): 0517-7630

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
307718	acetylcysteine 10 % Inhalation Solution	PSN	f56b4087-db48-4fd7-84ec-9c927962b805	11
307719	acetylcysteine 20 % Inhalation Solution	PSN	f56b4087-db48-4fd7-84ec-9c927962b805	11
307718	acetylcysteine 100 MG/ML Inhalation Solution	SCD	f56b4087-db48-4fd7-84ec-9c927962b805	11
307719	acetylcysteine 200 MG/ML Inhalation Solution	SCD	f56b4087-db48-4fd7-84ec-9c927962b805	11
307718	acetylcysteine 10 % Inhalation Solution	SY	f56b4087-db48-4fd7-84ec-9c927962b805	11
307719	acetylcysteine 20 % Inhalation Solution	SY	f56b4087-db48-4fd7-84ec-9c927962b805	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-7630-03	00517763003	3 VIAL, GLASS in 1 BOX (0517-7630-03) > 30 mL in 1 VIAL, GLASS	1995-10-01	0000-00-00	No	No	Current