FDA.reportPublic FDA data

Acetylcysteine

Product NDC
0517-7504
11-digit product format
005177504
Labeler code
0517
Product ID
0517-7504_2bcb9dd3-17f8-439e-a395-aa081c5cc4bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetylcysteine
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
American Regent, Inc.
Application
ANDA072489
Marketing category
ANDA
Marketing start
1995-10-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Acetylcysteine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETYLCYSTEINE100 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
0517-7504-25Acetylcysteine4 mL in 1 VIAL, GLASSINHALANT411
0517-7504-25Acetylcysteine25 in 1 TRAYINHALANT2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-7504-25ML - Milliliter0517-7504be771c08-983b-4b84-9425-281de1f8949812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETYLCYSTEINEACTIVE INGREDIENTWYQ7N0BPYCACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]7
ACETYLCYSTEINEACTIVE MOIETYWYQ7N0BPYCACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]7
WATERINACTIVE INGREDIENT059QF0KO0RACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]7
acetylcysteineACTIVE INGREDIENTWYQ7N0BPYCACETYLCYSTEINE INHALANT [CARDINAL HEALTH]2
acetylcysteineACTIVE MOIETYWYQ7N0BPYCACETYLCYSTEINE INHALANT [CARDINAL HEALTH]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KACETYLCYSTEINE INHALANT [CARDINAL HEALTH]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACETYLCYSTEINE INHALANT [CARDINAL HEALTH]2
waterINACTIVE INGREDIENT059QF0KO0RACETYLCYSTEINE INHALANT [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-7504ACETYLCYSTEINE INHALANT [AMERICAN REGENT, INC.]11Current NDC, Legacy NDC, 2 package rows20241219_f56b4087-db48-4fd7-84ec-9c927962b805.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307718acetylcysteine 10 % Inhalation SolutionPSNc90fca12-12fb-4cf6-bd6f-83bc0d95df8113
307719acetylcysteine 20 % Inhalation SolutionPSNc90fca12-12fb-4cf6-bd6f-83bc0d95df8113
307718acetylcysteine 100 MG/ML Inhalation SolutionSCDc90fca12-12fb-4cf6-bd6f-83bc0d95df8113
307719acetylcysteine 200 MG/ML Inhalation SolutionSCDc90fca12-12fb-4cf6-bd6f-83bc0d95df8113
307718acetylcysteine 10 % Inhalation SolutionSYc90fca12-12fb-4cf6-bd6f-83bc0d95df8113
307719acetylcysteine 20 % Inhalation SolutionSYc90fca12-12fb-4cf6-bd6f-83bc0d95df8113
307718acetylcysteine 10 % Inhalation SolutionPSNf56b4087-db48-4fd7-84ec-9c927962b80511
307719acetylcysteine 20 % Inhalation SolutionPSNf56b4087-db48-4fd7-84ec-9c927962b80511
307718acetylcysteine 100 MG/ML Inhalation SolutionSCDf56b4087-db48-4fd7-84ec-9c927962b80511
307719acetylcysteine 200 MG/ML Inhalation SolutionSCDf56b4087-db48-4fd7-84ec-9c927962b80511
307718acetylcysteine 10 % Inhalation SolutionSYf56b4087-db48-4fd7-84ec-9c927962b80511
307719acetylcysteine 20 % Inhalation SolutionSYf56b4087-db48-4fd7-84ec-9c927962b80511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0517-7504-250051775042525 VIAL, GLASS in 1 TRAY (0517-7504-25) / 4 mL in 1 VIAL, GLASS1995-10-010000-00-00NoNoCurrent