FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
21695-245
11-digit product format
216950245
Labeler code
21695
Product ID
21695-245_953ab65b-b157-41b3-8f90-98fa9d7f20c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Rebel Distributors Corp.
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
E
Listing certified through
2017-12-31
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
21695-245-202019-09-24C16284748780-1934fe258-49a7-48b1-e053-8cdaa90a720aAlbuterol Sulfate Inhalation Solution, 0.5%* Sterile (*Potency expressed as albuterol)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-245-20Albuterol Sulfate20 mL in 1 BOTTLE, GLASSSOLUTION201
21695-245-20Albuterol Sulfate1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-245-20ML - Milliliter21695-245a57c3c1e-84ad-492b-bc87-523a7fc6bf0b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-245ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20100907_953ab65b-b157-41b3-8f90-98fa9d7f20c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245314albuterol 0.5 % Inhalation SolutionPSN953ab65b-b157-41b3-8f90-98fa9d7f20c51
245314albuterol 5 MG/ML Inhalation SolutionSCD953ab65b-b157-41b3-8f90-98fa9d7f20c51
245314albuterol (as albuterol sulfate) 5 MG/ML Inhalation SolutionSY953ab65b-b157-41b3-8f90-98fa9d7f20c51
245314albuterol 0.5 % Concentrate for Inhalation SolutionSY953ab65b-b157-41b3-8f90-98fa9d7f20c51
245314albuterol 1 MG/ML (concentrate 0.5 % ) Inhalation SolutionSY953ab65b-b157-41b3-8f90-98fa9d7f20c51
245314albuterol 1 MG/ML (concentrate 5 MG/ML) Inhalation SolutionSY953ab65b-b157-41b3-8f90-98fa9d7f20c51
245314albuterol 2.5 MG per 0.5 ML Concentrate for Inhalation SolutionSY953ab65b-b157-41b3-8f90-98fa9d7f20c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-245-202169502452020 mL in 1 BOTTLE, GLASS20 mlHistorical