FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
21695-332
11-digit product format
216950332
Labeler code
21695
Product ID
21695-332_fd41a51d-d569-4368-a3b1-a12cb2472754
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Rebel Distributors Corp.
Application
ANDA074880
Marketing category
ANDA
Marketing start
1997-09-17
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
3 mg/3mL
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
21695-332-252019-09-24C16284748780-1934fe258-4b2a-48b1-e053-8cdaa90a720aAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml
21695-332-302019-09-24C16284748780-1934fe258-4b2a-48b1-e053-8cdaa90a720aAlbuterol Sulfate Inhalation Solution, 0.083% 2.5 mg*/3 ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-332-25Albuterol Sulfate1 in 1 CARTONSOLUTION12
21695-332-25Albuterol Sulfate25 in 1 POUCHSOLUTION252
21695-332-30Albuterol Sulfate1 in 1 CARTONSOLUTION12
21695-332-30Albuterol Sulfate30 in 1 POUCHSOLUTION302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-332-25ML - Milliliter21695-33248de902f-eea7-43ee-ba64-113ec0df669c12012-07-24
21695-332-30ML - Milliliter21695-3329d0bd835-6310-4910-a70d-5af7a004b36912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-332ALBUTEROL SULFATE SOLUTION [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 4 package rows20110914_2e439746-9808-4102-a92f-bf6c3f1e3513.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN2e439746-9808-4102-a92f-bf6c3f1e35132
630208albuterol 0.83 MG/ML Inhalation SolutionSCD2e439746-9808-4102-a92f-bf6c3f1e35132
630208albuterol 0.083 % Inhalation SolutionSY2e439746-9808-4102-a92f-bf6c3f1e35132
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY2e439746-9808-4102-a92f-bf6c3f1e35132
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY2e439746-9808-4102-a92f-bf6c3f1e35132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-332-25216950332251 in 1 CARTONHistorical
21695-332-30216950332301 in 1 CARTONHistorical