FDA.reportPublic FDA data

Albuterol sulfate

Product NDC
68180-963
11-digit product format
681800963
Labeler code
68180
Product ID
68180-963_ca017981-2752-46e0-9a66-418535597d31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Lupin 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
68180-963-01Albuterol sulfate1 in 1 CARTONAEROSOL, METERED113
68180-963-01Albuterol sulfate200 in 1 CANISTERAEROSOL, METERED20013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-963ALBUTEROL SULFATE AEROSOL, METERED [LUPIN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 2 package rows20250124_973b8686-c6ce-4280-85c4-c1e7ceab3c09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN973b8686-c6ce-4280-85c4-c1e7ceab3c0913
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD973b8686-c6ce-4280-85c4-c1e7ceab3c0913
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY973b8686-c6ce-4280-85c4-c1e7ceab3c0913
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda8
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN52e209ac-7156-4496-ba5a-42ee59d45deb8
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda8
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD52e209ac-7156-4496-ba5a-42ee59d45deb8
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY0cfb6c5d-eac2-4a1c-8a0f-6b00e819adda8
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY52e209ac-7156-4496-ba5a-42ee59d45deb8
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN32d954ee-9790-4beb-95db-72dbf8efa6394
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD32d954ee-9790-4beb-95db-72dbf8efa6394
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY32d954ee-9790-4beb-95db-72dbf8efa6394
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
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN4100bce5-096c-42e4-9e4e-d11a0ab597d52
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSNf44b325d-0f74-552c-e053-2995a90ac1c92
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD4100bce5-096c-42e4-9e4e-d11a0ab597d52
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDf44b325d-0f74-552c-e053-2995a90ac1c92
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY4100bce5-096c-42e4-9e4e-d11a0ab597d52
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSYf44b325d-0f74-552c-e053-2995a90ac1c92
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN99782bc8-56d9-41f8-935e-0d0de27f0c341
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN264e2145-c7d4-4f4f-aa5b-9fe48a7c5b471
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD99782bc8-56d9-41f8-935e-0d0de27f0c341
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD264e2145-c7d4-4f4f-aa5b-9fe48a7c5b471
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY99782bc8-56d9-41f8-935e-0d0de27f0c341
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY264e2145-c7d4-4f4f-aa5b-9fe48a7c5b471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-963-01681800963011 CANISTER in 1 CARTON (68180-963-01) / 200 AEROSOL, METERED in 1 CANISTER1 canister2020-08-250000-00-00NoNoCurrent