Home NDC 70710-1015 ACETYLCYSTEINE
Product NDC 70710-1015
11-digit product format 707101015
Labeler code 70710
Product ID 70710-1015_9f59a19f-ffa1-4ecf-98df-1e0f3de37ed1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetylcysteine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA208166
Marketing category ANDA
Marketing start 2019-01-17
Marketing end 0000-00-00
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 2023-12-31
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 · 4 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 70710-1015-8 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 70710-1015-8 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 A208166-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2018-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208166-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2018-07-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208166-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2018-07-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208166-001 ACETYLCYSTEINE 6GM/30ML (200MG/ML) INJECTABLE / INTRAVENOUS AP 2018-07-20 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1015 ACETYLCYSTEINE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] 5 Legacy NDC 20231111_c35cd2d4-6a28-4ba9-8cca-d6557fe50438.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70710-1015-8 70710101508 4 VIAL in 1 CARTON (70710-1015-8) > 30 mL in 1 VIAL (70710-1015-1) 4 vial 2019-01-17 0000-00-00 No No Current