FDA.reportPublic FDA data

ALBUTEROL SULFATE

Product NDC
59651-183
11-digit product format
596510183
Labeler code
59651
Product ID
59651-183_1e853c87-b534-65d2-e063-6394a90a7923
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Aurobindo Pharma Limited
Application
ANDA211888
Marketing category
ANDA
Marketing start
2020-04-20
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
59651-183-25ALBUTEROL SULFATE5 in 1 CARTONSOLUTION58
59651-183-25ALBUTEROL SULFATE5 in 1 POUCHSOLUTION58
59651-183-30ALBUTEROL SULFATE5 in 1 POUCHSOLUTION58
59651-183-30ALBUTEROL SULFATE6 in 1 CARTONSOLUTION68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-183-05ML - Milliliter59651-183cf18b530-6e22-4591-b447-b0b99ca5364c12025-10-14
59651-183-25ML - Milliliter59651-1837158268e-5e48-419a-8e4c-dda02aff694e12025-02-10
59651-183-30ML - Milliliter59651-183e5a65373-b825-4d94-886a-c1316988c0e412025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-183ALBUTEROL SULFATE SOLUTION [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 4 package rows20240801_78e6bee2-7113-46cf-8c97-dc61b0f7b94f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351137albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation SolutionPSN78e6bee2-7113-46cf-8c97-dc61b0f7b94f8
351136albuterol sulfate 0.042 % (1.25 MG/3 ML) Inhalation SolutionPSN78e6bee2-7113-46cf-8c97-dc61b0f7b94f8
351137albuterol 0.21 MG/ML Inhalation SolutionSCD78e6bee2-7113-46cf-8c97-dc61b0f7b94f8
351136albuterol 0.417 MG/ML Inhalation SolutionSCD78e6bee2-7113-46cf-8c97-dc61b0f7b94f8
351136albuterol 0.042 % (1.25 MG/3 ML) Inhalation SolutionSY78e6bee2-7113-46cf-8c97-dc61b0f7b94f8
351137albuterol 0.63 MG (albuterol sulfate 0.75 MG) per 3 ML Inhalation SolutionSY78e6bee2-7113-46cf-8c97-dc61b0f7b94f8
351136albuterol 1.25 MG (albuterol sulfate 1.5 MG) per 3 ML Inhalation SolutionSY78e6bee2-7113-46cf-8c97-dc61b0f7b94f8
351137albuterol sulfate 0.021 % (0.63 MG/3 ML) Inhalation SolutionSY78e6bee2-7113-46cf-8c97-dc61b0f7b94f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-183-25596510183255 POUCH in 1 CARTON (59651-183-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL5 pouch2020-04-200000-00-00NoNoCurrent
59651-183-30596510183306 POUCH in 1 CARTON (59651-183-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL6 pouch2024-07-29NoNoCurrent