FDA.reportPublic FDA data

ALBUTEROL SULFATE

Product NDC
65862-858
11-digit product format
658620858
Labeler code
65862
Product ID
65862-858_235055b3-2ceb-89e9-e063-6394a90aee19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Aurobindo Pharma Limited
Application
ANDA206224
Marketing category
ANDA
Marketing start
2017-10-17
Substance
ALBUTEROL SULFATE
Active strength
.83 mg/mL
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.83 mg/mL

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
65862-858-03ALBUTEROL SULFATE1 in 1 POUCHSOLUTION17
65862-858-03ALBUTEROL SULFATE30 in 1 CARTONSOLUTION307
65862-858-25ALBUTEROL SULFATE5 in 1 CARTONSOLUTION57
65862-858-25ALBUTEROL SULFATE5 in 1 POUCHSOLUTION57
65862-858-30ALBUTEROL SULFATE5 in 1 POUCHSOLUTION57
65862-858-30ALBUTEROL SULFATE6 in 1 CARTONSOLUTION67
65862-858-60ALBUTEROL SULFATE5 in 1 POUCHSOLUTION57
65862-858-60ALBUTEROL SULFATE12 in 1 CARTONSOLUTION127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-858-25ML - Milliliter65862-85857808251-2ea4-4614-879b-3abfe8a6684812025-02-10
65862-858-30ML - Milliliter65862-8584f147d70-9b3b-45f8-8e31-1d72e56abfe312025-02-10
65862-858-60ML - Milliliter65862-8588cc2e90d-0e5e-43be-b87c-d822d856cbce12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-858ALBUTEROL SULFATE SOLUTION [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 8 package rows20241001_eafa5b05-d692-48e7-a413-30f847547eb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSNeafa5b05-d692-48e7-a413-30f847547eb27
630208albuterol 0.83 MG/ML Inhalation SolutionSCDeafa5b05-d692-48e7-a413-30f847547eb27
630208albuterol 0.083 % Inhalation SolutionSYeafa5b05-d692-48e7-a413-30f847547eb27
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYeafa5b05-d692-48e7-a413-30f847547eb27
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYeafa5b05-d692-48e7-a413-30f847547eb27
630208albuterol sulfate 0.083 % Inhalation SolutionPSN54172384-9726-4a11-901e-3fb8f1baccae1
630208albuterol 0.83 MG/ML Inhalation SolutionSCD54172384-9726-4a11-901e-3fb8f1baccae1
630208albuterol 0.083 % Inhalation SolutionSY54172384-9726-4a11-901e-3fb8f1baccae1
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY54172384-9726-4a11-901e-3fb8f1baccae1
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY54172384-9726-4a11-901e-3fb8f1baccae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-858-036586208580330 POUCH in 1 CARTON (65862-858-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE30 pouch2017-10-170000-00-00NoNoCurrent
65862-858-25658620858255 POUCH in 1 CARTON (65862-858-25) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE5 pouch2017-10-170000-00-00NoNoCurrent
65862-858-30658620858306 POUCH in 1 CARTON (65862-858-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE6 pouch2017-10-170000-00-00NoNoCurrent
65862-858-606586208586012 POUCH in 1 CARTON (65862-858-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE12 pouch2017-10-170000-00-00NoNoCurrent