Acetylcysteine

Product NDC
55154-5730
11-digit product format
551545730
Labeler code
55154
Product ID
55154-5730_1c27f160-8d78-462c-91e6-c9a89b7dc4a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetylcysteine
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
Cardinal Health 107, LLC
Application
ANDA072489
Marketing category
ANDA
Marketing start
2011-05-06
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
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
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
55154-5730-5Acetylcysteine5 in 1 BAGINHALANT513
55154-5730-5Acetylcysteine4 mL in 1 VIAL, GLASSINHALANT413

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
55154-5730ACETYLCYSTEINE INHALANT [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 2 package rows20240823_c90fca12-12fb-4cf6-bd6f-83bc0d95df81.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-5730-5551545730055 VIAL, GLASS in 1 BAG (55154-5730-5) / 4 mL in 1 VIAL, GLASS2011-05-060000-00-00NoNoCurrent