Home NDC 68462-946 Acetylcysteine
Product NDC 68462-946
11-digit product format 684620946
Labeler code 68462
Product ID 68462-946_9a22e853-f45c-4bda-87e1-5aaf8e61a225
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetylcysteine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA213693
Marketing category ANDA
Marketing start 2024-09-25
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 A213693-001 ACETYLCYSTEINE ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213693-001 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.
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 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213693-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2022-02-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 68462-946-12 Acetylcysteine 4 in 1 CARTON INJECTION, SOLUTION 4 3 68462-946-30 Acetylcysteine 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-946 ACETYLCYSTEINE INJECTION, SOLUTION [GLENMARK PHARMACEUTICALS INC., USA] 2 Current NDC, 2 package rows 20250326_f811ddfc-d7c1-4637-ae81-80c38a77cb80.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68462-946-12 68462094612 4 VIAL, SINGLE-DOSE in 1 CARTON (68462-946-12) / 30 mL in 1 VIAL, SINGLE-DOSE (68462-946-30) 2024-09-25 No No Current 68462-946-30 68462094630 30 mL in 1 VIAL, SINGLE-DOSE 30 ml Historical