Home NDC 0574-0805 acetylcysteine
Product NDC 0574-0805
11-digit product format 005740805
Labeler code 0574
Product ID 0574-0805_b123834f-a908-4e77-bf87-32dffefa20f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetylcysteine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Padagis US LLC
Application NDA021539
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2012-12-20
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 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 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 · 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 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…2022-10-28 04:53 UTC 2022-10 N021539-001 ACETADOTE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2004-01-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021539-001 ACETADOTE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2004-01-23 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 6 · 204 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021539-001 9327028 2031-07-21 U-1839 2016-05-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021539-001 8722738 2032-04-06 U-1373 2014-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021539-001 8399445 2025-08-24 U-1373 2013-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021539-001 8653061 2025-08-24 U-1373 2014-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021539-001 8148356 2026-05-21 Drug product 2012-04-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021539-001 9327028 2031-07-21 U-1839 2016-05-18 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 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…
Additional Listing Data#
Finished product Yes
Brand name base acetylcysteine
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 465377 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0574-0805-30 acetylcysteine 30 mL in 1 VIAL INJECTION 30 12 0574-0805-30 acetylcysteine 4 in 1 CARTON INJECTION 4 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0574-0805 ACETYLCYSTEINE INJECTION [PADAGIS US LLC] 11 Current NDC, Legacy NDC, 2 package rows 20241101_9d305722-e74f-4f48-8d2c-0daa99144749.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0574-0805-30 00574080530 4 VIAL in 1 CARTON (0574-0805-30) / 30 mL in 1 VIAL 4 vial 2012-12-20 0000-00-00 No No Current