ACETYLCYSTEINE INJECTION

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-10-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 21:51:23

Label at a glance#

ProductACETYLCYSTEINE

Active ingredientACETYLCYSTEINE

Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – Vial Label

NDC 70771-1412-1

Acetylcysteine Injection

6 g/30 mL

(200 mg/mL)

MUST BE FURTHER DILUTED

PRIOR TO INTRAVENOUS USE

30 mL Sterile

Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – Carton Label

NDC 70771-1412-8

Acetylcysteine Injection

6 g/30 mL

(200 mg/mL)

MUST BE FURTHER DILUTED

PRIOR TO INTRAVENOUS USE

4 X 30 mL Sterile Vials

Rx only

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1412	ACETYLCYSTEINE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]	3	Legacy NDC	20221019_c09faafd-af53-4fed-ae87-d16494758945.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

ACETYLCYSTEINE
EDETATE DISODIUM
NITROGEN
SODIUM HYDROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1412	70771-1412-1, 70771-1412-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETYLCYSTEINE	WYQ7N0BPYC	ACTIB
EDETATE DISODIUM	7FLD91C86K	IACT
NITROGEN	N762921K75	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML · Source PDF

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 43.

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
A208166-001	ACETYLCYSTEINE	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP		2018-07-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208166-001	AP

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 · 43 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
2026-09-14 22:38:34	2026-08	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208166-001	ACETYLCYSTEINE	6GM/30ML (200MG/ML)	INJECTABLE / INTRAVENOUS	AP	2018-07-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208166-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208166-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208166-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208166-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208166-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208166-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208166-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208166-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208166-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208166-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208166-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208166-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208166-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208166-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208166-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208166-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208166-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208166-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208166-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208166-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208166-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208166-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208166-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208166-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208166-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208166-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208166-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208166-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208166-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208166-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208166-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208166-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208166-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208166-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208166-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208166-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208166-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208166-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208166-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208166-001	AP	1	`f41ea6bd6efb…`

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
331e438b-9365-4bad-908b-8b4b76d7a5ff			c09faafd-af53-4fed-ae87-d16494758945	2025-05-31		Exact identifier spl set id: c09faafd-af53-4fed-ae87-d16494758945

Reported adverse events (FAERS/openFDA)#

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