FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
0378-7057
11-digit product format
003787057
Labeler code
0378
Product ID
0378-7057_de8e18d1-bd6b-484a-a7b4-3c286c8ae917
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA214531
Marketing category
ANDA
Marketing start
2022-10-07
Substance
ALBUTEROL SULFATE
Active strength
.63 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 SULFATE.63 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui351136, 351137

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
0378-7057-52Albuterol Sulfate5 in 1 CARTONSOLUTION52
0378-7057-98Albuterol Sulfate5 in 1 POUCHSOLUTION52
0378-7057-98Albuterol Sulfate3 mL in 1 VIALSOLUTION32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7057-52ML - Milliliter0378-70572f3b2cf3-8a5f-4e8b-80a1-a8fdefd699f212022-11-07
0378-7057-98ML - Milliliter0378-705752e69880-2d64-47a6-b2ea-e271f3ea247412022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7057ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 3 package rows20221029_9e6e982b-7dfe-45b8-aa76-754e8d2a8ef6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351137albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation SolutionPSN9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62
351136albuterol sulfate 0.042 % (1.25 MG/3 ML) Inhalation SolutionPSN9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62
351137albuterol 0.21 MG/ML Inhalation SolutionSCD9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62
351136albuterol 0.417 MG/ML Inhalation SolutionSCD9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62
351136albuterol 0.042 % (1.25 MG/3 ML) Inhalation SolutionSY9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62
351137albuterol 0.63 MG (albuterol sulfate 0.75 MG) per 3 ML Inhalation SolutionSY9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62
351136albuterol 1.25 MG (albuterol sulfate 1.5 MG) per 3 ML Inhalation SolutionSY9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62
351137albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation SolutionSY9e6e982b-7dfe-45b8-aa76-754e8d2a8ef62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7057-52003787057525 POUCH in 1 CARTON (0378-7057-52) / 5 VIAL in 1 POUCH (0378-7057-98) / 3 mL in 1 VIAL5 pouch2022-10-070000-00-00NoNoCurrent
0378-7057-98003787057985 in 1 POUCHHistorical