Home NDC 0574-0815 Acetylcysteine
Product NDC 0574-0815
11-digit product format 005740815
Labeler code 0574
Product ID 0574-0815_1cc266a0-3499-42da-93b3-a3ed19687f4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetylcysteine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Paddock Laboratories, LLC
Application NDA021539
Marketing category NDA
Marketing start 2013-10-15
Marketing end 2021-02-01
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 24 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 0574-0815-30 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 0574-0815-30 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 0574-0815-30 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 0574-0815-30 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 0574-0815-30 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 0574-0815-30 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 0574-0815-30 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 0574-0815-30 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 0574-0815-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0574-0815-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0574-0815-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0574-0815-30 557ba5c1ecfa…9c80585c8c6e…
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 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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021539-001 ACETADOTE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP RLD, RS 2004-01-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 6 · 201 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021539-001 8722738 2032-04-06 U-1373 2014-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021539-001 8399445 2025-08-24 U-1373 2013-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021539-001 8653061 2025-08-24 U-1373 2014-02-24 d8e5a09893c0…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 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…
DailyMed Socrata Ingredients# 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.