FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
0781-7296
11-digit product format
007817296
Labeler code
0781
Product ID
0781-7296_44ec30c6-e178-d2ed-e063-6394a90a25a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Sandoz Inc
Application
NDA020503
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-03-15
Substance
ALBUTEROL SULFATE
Active strength
108 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 SULFATE108 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui2123111

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
00358076-c817-430b-b924-11d717dc307cProduct name120160718
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-7296-85Albuterol Sulfate1 in 1 CARTONAEROSOL, METERED16
0781-7296-85Albuterol Sulfate200 in 1 CANISTERAEROSOL, METERED2006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-7296ALBUTEROL SULFATE AEROSOL, METERED [SANDOZ INC]5Current NDC, Legacy NDC, 2 package rows20241103_f8a2c4b7-a162-48ab-90b0-350e4da25c66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNf8a2c4b7-a162-48ab-90b0-350e4da25c666
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNd6acb5a7-555a-463a-ae65-2911d6789b426
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDf8a2c4b7-a162-48ab-90b0-350e4da25c666
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDd6acb5a7-555a-463a-ae65-2911d6789b426
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYf8a2c4b7-a162-48ab-90b0-350e4da25c666
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYd6acb5a7-555a-463a-ae65-2911d6789b426
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNbae7a52f-504b-416e-afdd-e6853e2d59445
212033aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874BAYER Aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870225EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBDbae7a52f-504b-416e-afdd-e6853e2d59445
212033aspirin 325 MG Oral TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4000 MG Chewable TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870225NDA020800 0.15 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYbae7a52f-504b-416e-afdd-e6853e2d59445
212033ASA 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SYbae7a52f-504b-416e-afdd-e6853e2d59445
211874Bayer Aspirin 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870225epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 400 MCG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039NTG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039TNG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN58d78805-3e8c-4859-b2e0-e3089f9252804
212033aspirin 325 MG Oral TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
211874BAYER Aspirin 325 MG Oral TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN58d78805-3e8c-4859-b2e0-e3089f9252804
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSN58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4 GM Chewable TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 0.4 MG Sublingual TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBD58d78805-3e8c-4859-b2e0-e3089f9252804
212033aspirin 325 MG Oral TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4000 MG Chewable TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD58d78805-3e8c-4859-b2e0-e3089f9252804
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 0.4 MG Sublingual TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY58d78805-3e8c-4859-b2e0-e3089f9252804
212033ASA 325 MG Oral TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SY58d78805-3e8c-4859-b2e0-e3089f9252804
211874Bayer Aspirin 325 MG Oral TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSY58d78805-3e8c-4859-b2e0-e3089f9252804
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSY58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4 GM Chewable TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 400 MCG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039NTG 0.4 MG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039TNG 0.4 MG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN9d434eb2-93a6-4a44-bb41-03517f8bbb682
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD9d434eb2-93a6-4a44-bb41-03517f8bbb682
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY9d434eb2-93a6-4a44-bb41-03517f8bbb682
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNc9ec73cb-1ba2-529b-e053-2a95a90a9eee1
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN32dbec5e-044a-40b6-9b88-e1396c4b4b6e1
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d1
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDc9ec73cb-1ba2-529b-e053-2a95a90a9eee1
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD32dbec5e-044a-40b6-9b88-e1396c4b4b6e1
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d1
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYc9ec73cb-1ba2-529b-e053-2a95a90a9eee1
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d1
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY32dbec5e-044a-40b6-9b88-e1396c4b4b6e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-7296-85007817296851 CANISTER in 1 CARTON (0781-7296-85) / 200 AEROSOL, METERED in 1 CANISTER1 canister2021-03-150000-00-00NoNoCurrent