Acetylcysteine

Product NDC: 0409-3307
11-digit product format: 004093307
Labeler code: 0409
Product ID: 0409-3307_6c12470d-0f1a-4085-938d-121df34c3cb0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETYLCYSTEINE
Dosage form: SOLUTION
Route: ORAL; RESPIRATORY (INHALATION)
Labeler: Hospira, Inc.
Application: ANDA073664
Marketing category: ANDA
Marketing start: 2005-04-30
Substance: ACETYLCYSTEINE
Active strength: 100 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: 2027-12-31
Current FDA listing: Yes

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
A073664-001	ACETYLCYSTEINE	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN		1994-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073664-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073664-001	ACETYLCYSTEINE	10%	SOLUTION / INHALATION, ORAL	AN	1994-08-30	`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	A073664-001	AN	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073664-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073664-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073664-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073664-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073664-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073664-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073664-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073664-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073664-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073664-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073664-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073664-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073664-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073664-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073664-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073664-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073664-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073664-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073664-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073664-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073664-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073664-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073664-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073664-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073664-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073664-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073664-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073664-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073664-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073664-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073664-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073664-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073664-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073664-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073664-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073664-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073664-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073664-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073664-001	AN	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetylcysteine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETYLCYSTEINE	100 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
307718	Internal RxNorm lookup
307719	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
5558a5f5-e821-473b-7d8a-5d33d09f0586	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0409-3307-03	Acetylcysteine	3 in 1 CARTON	SOLUTION	3		22
0409-3307-11	Acetylcysteine	30 mL in 1 VIAL	SOLUTION	30		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-3307-03	ML - Milliliter	0409-3307	e463f813-16b0-4eb9-882c-0bdbf4fc2a93	1	2012-07-24
0409-3307-11	ML - Milliliter	0409-3307	84f2cf55-2950-48a4-a860-a6bd90a34440	1	2020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETYLCYSTEINE	ACTIVE INGREDIENT	WYQ7N0BPYC	ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]	13
ACETYLCYSTEINE	ACTIVE MOIETY	WYQ7N0BPYC	ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]	13
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]	13
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]	13
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-3307	ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]	20	Current NDC, Legacy NDC, 2 package rows	20241018_5558a5f5-e821-473b-7d8a-5d33d09f0586.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetylcysteine	ACETYLCYSTEINE	Hospira, Inc.	5558a5f5-e821-473b-7d8a-5d33d09f0586	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073664 application number: ANDA073664 ndc (product): 0409-3307

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	5558a5f5-e821-473b-7d8a-5d33d09f0586	22
307719	acetylcysteine 20 % Inhalation Solution	PSN	5558a5f5-e821-473b-7d8a-5d33d09f0586	22
307718	acetylcysteine 100 MG/ML Inhalation Solution	SCD	5558a5f5-e821-473b-7d8a-5d33d09f0586	22
307719	acetylcysteine 200 MG/ML Inhalation Solution	SCD	5558a5f5-e821-473b-7d8a-5d33d09f0586	22
307718	acetylcysteine 10 % Inhalation Solution	SY	5558a5f5-e821-473b-7d8a-5d33d09f0586	22
307719	acetylcysteine 20 % Inhalation Solution	SY	5558a5f5-e821-473b-7d8a-5d33d09f0586	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-3307-03	00409330703	3 VIAL in 1 CARTON (0409-3307-03) / 30 mL in 1 VIAL (0409-3307-11)	3 vial	2005-04-30	0000-00-00	No	No	Current
0409-3307-11	00409330711	30 mL in 1 VIAL	30 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETYLCYSTEINE Solution, USP 10% and 20% Teartop Vials	Hospira, Inc.	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	22