Home NDC 70069-019 Acetylcysteine
Product NDC 70069-019
11-digit product format 700690019
Labeler code 70069
Product ID 70069-019_af1a403e-02e4-4d18-bb00-6629a8e7c261
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acetylcysteine
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Somerset Therapeutics, LLC
Application ANDA219194
Marketing category ANDA
Marketing start 2025-03-04
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 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 A219194-001 ACETYLCYSTEINE ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-02-12 A219194-002 ACETYLCYSTEINE ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-02-12
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 A219194-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219194-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219194-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-02-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219194-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219194-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-02-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219194-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219194-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-02-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219194-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219194-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-02-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219194-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-02-12 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219194-001 ACETYLCYSTEINE 10% SOLUTION / INHALATION, ORAL AN 2025-02-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219194-002 ACETYLCYSTEINE 20% SOLUTION / INHALATION, ORAL AN 2025-02-12 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 · 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 70069-019-01 Acetylcysteine 4 mL in 1 VIAL SOLUTION 4 7 70069-019-25 Acetylcysteine 25 in 1 CARTON SOLUTION 25 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-019 ACETYLCYSTEINE SOLUTION [SOMERSET THERAPEUTICS, LLC] 4 Current NDC, 2 package rows 20250306_d50c8ab6-26f8-4669-89d1-c4d26698159a.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 70069-019-01 70069001901 4 mL in 1 VIAL 4 ml Historical 70069-019-25 70069001925 25 VIAL in 1 CARTON (70069-019-25) / 4 mL in 1 VIAL (70069-019-01) 25 vial 2025-03-04 No No Current