Albuterol Sulfate

Product NDC
50383-741
11-digit product format
503830741
Labeler code
50383
Product ID
50383-741_8dcd2429-1d74-4612-8dac-9df6bc3a807c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Akorn
Application
ANDA074543
Marketing category
ANDA
Marketing start
1998-01-15
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-741-202025-09-10C16284748780-11030e365-178b-111a-e063-dadaa90a10e234b6ab14-9ed5-4651-9be6-84685e6aa919
50383-741-202024-01-30C16284748780-11030e365-178b-111a-e063-dadaa90a10e234b6ab14-9ed5-4651-9be6-84685e6aa919

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-741-20ML - Milliliter50383-741bbebf9c1-8994-44d6-9b9b-398bb4185ef112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-741ALBUTEROL SULFATE SOLUTION [AKORN]8Legacy NDC20220302_34b6ab14-9ed5-4651-9be6-84685e6aa919.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245314albuterol 0.5 % Inhalation SolutionPSN1bb952b7-8826-40a1-ac7b-38ec1bd9b94e1
245314albuterol 5 MG/ML Inhalation SolutionSCD1bb952b7-8826-40a1-ac7b-38ec1bd9b94e1
245314albuterol (as albuterol sulfate) 5 MG/ML Inhalation SolutionSY1bb952b7-8826-40a1-ac7b-38ec1bd9b94e1
245314albuterol 0.5 % Concentrate for Inhalation SolutionSY1bb952b7-8826-40a1-ac7b-38ec1bd9b94e1
245314albuterol 1 MG/ML (concentrate 0.5 % ) Inhalation SolutionSY1bb952b7-8826-40a1-ac7b-38ec1bd9b94e1
245314albuterol 1 MG/ML (concentrate 5 MG/ML) Inhalation SolutionSY1bb952b7-8826-40a1-ac7b-38ec1bd9b94e1
245314albuterol 2.5 MG per 0.5 ML Concentrate for Inhalation SolutionSY1bb952b7-8826-40a1-ac7b-38ec1bd9b94e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50383-741-20503830741201 BOTTLE, GLASS in 1 CARTON (50383-741-20) > 20 mL in 1 BOTTLE, GLASS1998-01-150000-00-00NoNoCurrent