FDA.reportPublic FDA data

Albuterol sulfate

Product NDC
68071-2300
11-digit product format
680712300
Labeler code
68071
Product ID
68071-2300_1d786176-599e-19ad-e063-6294a90a9237
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209954
Marketing category
ANDA
Marketing start
2020-08-25
Substance
ALBUTEROL SULFATE
Active strength
90 ug/1
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 SULFATE90 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui2123072

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
68071-2300-22024-07-25C16284748780-11030e365-1649-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALBUTEROL SULFATE INHALATION AEROSOL safely and effectively. See full prescribing information for ALBUTEROL SULFATE INHALATION AEROSOL. ALBUTEROL SULFATE inhalation aerosol, for oral use. Initial U.S. Approval: 1981
68071-2300-22024-01-30C16284748780-11030e365-1649-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ALBUTEROL SULFATE INHALATION AEROSOL safely and effectively. See full prescribing information for ALBUTEROL SULFATE INHALATION AEROSOL. ALBUTEROL SULFATE inhalation aerosol, for oral use. Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2300-2Albuterol sulfate1 in 1 CARTONAEROSOL, METERED13
68071-2300-2Albuterol sulfate200 in 1 CANISTERAEROSOL, METERED2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2300ALBUTEROL SULFATE AEROSOL, METERED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 2 package rows20240726_b478d9e9-9704-6af2-e053-2995a90aafd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSNb478d9e9-9704-6af2-e053-2995a90aafd43
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDb478d9e9-9704-6af2-e053-2995a90aafd43
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSYb478d9e9-9704-6af2-e053-2995a90aafd43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2300-2680712300021 CANISTER in 1 CARTON (68071-2300-2) / 200 AEROSOL, METERED in 1 CANISTER1 canister2020-11-190000-00-00NoNoCurrent