Home NDC 42494-435 Acetylcysteine
Product NDC 42494-435
11-digit product format 424940435
Labeler code 42494
Product ID 42494-435_a0973436-d684-4b3c-88ef-103e3005e6bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetylcysteine
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Cameron Pharmaceuticals
Application ANDA214177
Marketing category ANDA
Marketing start 2025-08-21
Substance ACETYLCYSTEINE
Active strength 100 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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214177-001 ACETYLCYSTEINE ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-03-14 A214177-002 ACETYLCYSTEINE ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-02-19 14:30 UTC 2026-02 A214177-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214177-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214177-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214177-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214177-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214177-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-03-14 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214177-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-03-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214177-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-03-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Acetylcysteine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETYLCYSTEINE 100 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307718 Internal RxNorm lookup 307719 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 42494-435-25 Acetylcysteine 4 mL in 1 VIAL SOLUTION 4 1 42494-435-25 Acetylcysteine 25 in 1 CARTON SOLUTION 25 1
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 42494-435-25 42494043525 25 VIAL in 1 CARTON (42494-435-25) / 4 mL in 1 VIAL 25 vial 2025-08-21 No No Current