FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
60687-395
11-digit product format
606870395
Labeler code
60687
Product ID
60687-395_199e7908-e7e3-15d7-e063-6294a90ad53f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
American Health Packaging
Application
ANDA077839
Marketing category
ANDA
Marketing start
2019-01-11
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2.5 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui630208

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-395-79Albuterol Sulfate3 mL in 1 AMPULESOLUTION34
60687-395-79Albuterol Sulfate1 in 1 POUCHSOLUTION14
60687-395-83Albuterol Sulfate30 in 1 CARTONSOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-395ALBUTEROL SULFATE SOLUTION [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 3 package rows20240531_4aec7f59-b429-4b0e-a779-8df1dd8f80d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol 0.83 MG/ML Inhalation SolutionSCD6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol 0.083 % Inhalation SolutionSY6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY6ec88f64-66a2-4ca9-9913-c192fc33f88b5
630208albuterol sulfate 0.083 % Inhalation SolutionPSN4aec7f59-b429-4b0e-a779-8df1dd8f80d74
630208albuterol 0.83 MG/ML Inhalation SolutionSCD4aec7f59-b429-4b0e-a779-8df1dd8f80d74
630208albuterol 0.083 % Inhalation SolutionSY4aec7f59-b429-4b0e-a779-8df1dd8f80d74
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY4aec7f59-b429-4b0e-a779-8df1dd8f80d74
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY4aec7f59-b429-4b0e-a779-8df1dd8f80d74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-395-79606870395793 mL in 1 AMPULE3 mlHistorical
60687-395-836068703958330 POUCH in 1 CARTON (60687-395-83) / 1 AMPULE in 1 POUCH (60687-395-79) / 3 mL in 1 AMPULE30 pouch2019-01-110000-00-00NoNoCurrent