Home NDC 63323-963 Acetylcysteine
Product NDC 63323-963
11-digit product format 633230963
Labeler code 63323
Product ID 63323-963_2d292664-30db-4cb4-8e38-21b5d684c635
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetylcysteine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA200644
Marketing category ANDA
Marketing start 2012-11-09
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 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 A200644-001 ACETYLCYSTEINE ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200644-001 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 · 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 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200644-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2012-11-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 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 63323-963-21 Acetylcysteine 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 13 63323-963-30 Acetylcysteine 4 in 1 CARTON INJECTION, SOLUTION 4 13 63323-963-41 Acetylcysteine 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 2 63323-963-44 Acetylcysteine 4 in 1 CARTON INJECTION, SOLUTION 4 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-963 ACETYLCYSTEINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 13 Current NDC, Legacy NDC, 2 package rows 20221103_d990ef51-ced2-4359-b99b-092334d2dc9b.zip 63323-963 ACETYLCYSTEINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20221103_8cca4e4c-85a2-d575-e053-2995a90a6599.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 63323-963-21 63323096321 30 mL in 1 VIAL, SINGLE-DOSE 30 ml Historical 63323-963-30 63323096330 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-30) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-963-21) 2012-11-09 0000-00-00 No No Current 63323-963-41 63323096341 30 mL in 1 VIAL, SINGLE-DOSE 30 ml Historical 63323-963-44 63323096344 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-44) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-963-41) 2012-11-09 0000-00-00 No No Current