Acetylcysteine

Product NDC: 63323-692
Requested package NDC: 63323-692-10
11-digit product format: 633230692
Labeler code: 63323
Product ID: 63323-692_da00a3b4-d7e8-464b-a13f-422b445de8ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ACETYLCYSTEINE
Dosage form: SOLUTION
Route: ORAL; RESPIRATORY (INHALATION)
Labeler: Fresenius Kabi USA, LLC
Application: ANDA203853
Marketing category: ANDA
Marketing start: 2012-09-01
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

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
A203853-001	ACETYLCYSTEINE	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN		2012-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203853-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203853-001	ACETYLCYSTEINE	20%	SOLUTION / INHALATION, ORAL	AN	2012-06-21	`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	A203853-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203853-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203853-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203853-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203853-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203853-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203853-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203853-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203853-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203853-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203853-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203853-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203853-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203853-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203853-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203853-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203853-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203853-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203853-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203853-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203853-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203853-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203853-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203853-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203853-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203853-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203853-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203853-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203853-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203853-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203853-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203853-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203853-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203853-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203853-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203853-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203853-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203853-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203853-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203853-001	AN	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetylcysteine
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
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
75b48fab-cef6-465c-a1e0-d085b3988bc4	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
63323-692-10	Acetylcysteine	3 in 1 CARTON	SOLUTION	3		11
63323-692-22	Acetylcysteine	10 mL in 1 VIAL	SOLUTION	10		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-692-10	ML - Milliliter	63323-692	0cd3cd0a-965d-4f4a-81cd-cad7e69bc967	1	2013-11-04
63323-692-22	ML - Milliliter	63323-692	8c6af7a0-8326-4664-b073-9d174554c358	1	2024-09-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETYLCYSTEINE	ACTIVE INGREDIENT	WYQ7N0BPYC	ACETYLCYSTEINE SOLUTION [FRESENIUS KABI USA, LLC]	7
ACETYLCYSTEINE	ACTIVE MOIETY	WYQ7N0BPYC	ACETYLCYSTEINE SOLUTION [FRESENIUS KABI USA, LLC]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ACETYLCYSTEINE SOLUTION [FRESENIUS KABI USA, LLC]	7
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ACETYLCYSTEINE SOLUTION [FRESENIUS KABI USA, LLC]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ACETYLCYSTEINE SOLUTION [FRESENIUS KABI USA, LLC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-692	ACETYLCYSTEINE SOLUTION [FRESENIUS KABI USA, LLC]	11	Current NDC, Legacy NDC, 2 package rows	20240823_75b48fab-cef6-465c-a1e0-d085b3988bc4.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	Fresenius Kabi USA, LLC	75b48fab-cef6-465c-a1e0-d085b3988bc4	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203853 application number: ANDA203853 ndc (package): 63323-692-10 ndc (product): 63323-692 ndc11 (package): 63323069210
Acetylcysteine	ACETYLCYSTEINE	Fresenius Kabi USA, LLC	8d81039e-20ef-5144-e053-2a95a90a89fd	2022-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203853 application number: ANDA203853

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	75b48fab-cef6-465c-a1e0-d085b3988bc4	11
307719	acetylcysteine 20 % Inhalation Solution	PSN	75b48fab-cef6-465c-a1e0-d085b3988bc4	11
307718	acetylcysteine 100 MG/ML Inhalation Solution	SCD	75b48fab-cef6-465c-a1e0-d085b3988bc4	11
307719	acetylcysteine 200 MG/ML Inhalation Solution	SCD	75b48fab-cef6-465c-a1e0-d085b3988bc4	11
307718	acetylcysteine 10 % Inhalation Solution	SY	75b48fab-cef6-465c-a1e0-d085b3988bc4	11
307719	acetylcysteine 20 % Inhalation Solution	SY	75b48fab-cef6-465c-a1e0-d085b3988bc4	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-692-10	63323069210	3 VIAL in 1 CARTON (63323-692-10) / 10 mL in 1 VIAL (63323-692-22)	3 vial	2012-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETYLCYSTEINE SOLUTION, USP	Fresenius Kabi USA, LLC \| GLAND PHARMA LIMITED	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	11