FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Acetylcysteine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETYLCYSTEINE200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWYQ7N0BPYC
Rxcui307718, 307719

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-019-01Acetylcysteine4 mL in 1 VIALSOLUTION47
70069-019-25Acetylcysteine25 in 1 CARTONSOLUTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-019-01ML - Milliliter70069-0195eeee254-29bf-4e18-aea7-dce0697b728512025-05-14
70069-019-25ML - Milliliter70069-0199b077df8-4966-49c1-bade-2941e8ba872d12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-019ACETYLCYSTEINE SOLUTION [SOMERSET THERAPEUTICS, LLC]4Current NDC, 2 package rows20250306_d50c8ab6-26f8-4669-89d1-c4d26698159a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307718acetylcysteine 10 % Inhalation SolutionPSNd50c8ab6-26f8-4669-89d1-c4d26698159a7
307719acetylcysteine 20 % Inhalation SolutionPSNd50c8ab6-26f8-4669-89d1-c4d26698159a7
307718acetylcysteine 100 MG/ML Inhalation SolutionSCDd50c8ab6-26f8-4669-89d1-c4d26698159a7
307719acetylcysteine 200 MG/ML Inhalation SolutionSCDd50c8ab6-26f8-4669-89d1-c4d26698159a7
307718acetylcysteine 10 % Inhalation SolutionSYd50c8ab6-26f8-4669-89d1-c4d26698159a7
307719acetylcysteine 20 % Inhalation SolutionSYd50c8ab6-26f8-4669-89d1-c4d26698159a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-019-01700690019014 mL in 1 VIAL4 mlHistorical
70069-019-257006900192525 VIAL in 1 CARTON (70069-019-25) / 4 mL in 1 VIAL (70069-019-01) 25 vial2025-03-04NoNoCurrent