FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
0093-3174
11-digit product format
000933174
Labeler code
0093
Product ID
0093-3174_d9fc7dd4-8c8c-4c83-a6b7-02d984f4135b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Teva Pharmaceuticals USA, Inc.
Application
NDA021457
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-01-16
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
Brand name suffix
HFA
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
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
95250459-30e4-45c1-b08a-993044f49109Product name220250805
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
36390b75-5438-47d3-af60-732a654e9025Product name220220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
00358076-c817-430b-b924-11d717dc307cProduct name120160718
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-3174-31Albuterol SulfateHFA200 in 1 INHALERAEROSOL, METERED20015
0093-3174-31Albuterol SulfateHFA1 in 1 CARTONAEROSOL, METERED115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3174-31GM - Gram0093-3174b782a6f5-d54d-48f6-af90-bd547bf78d5412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3174ALBUTEROL SULFATE HFA (ALBUTEROL SULFATE) AEROSOL, METERED [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20230201_7bb5b6dd-9105-4ee7-b205-ed79cf4b371b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN7bb5b6dd-9105-4ee7-b205-ed79cf4b371b15
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD7bb5b6dd-9105-4ee7-b205-ed79cf4b371b15
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY7bb5b6dd-9105-4ee7-b205-ed79cf4b371b15
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSNd617e361-5c03-45ac-9bbe-0fa418edb19f5
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDd617e361-5c03-45ac-9bbe-0fa418edb19f5
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSYd617e361-5c03-45ac-9bbe-0fa418edb19f5
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN8c278b6f-d32b-b750-e053-2995a90ad7e94
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSNa69489f7-4ffb-4cd1-b2d2-002f48e84f514
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD8c278b6f-d32b-b750-e053-2995a90ad7e94
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDa69489f7-4ffb-4cd1-b2d2-002f48e84f514
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY8c278b6f-d32b-b750-e053-2995a90ad7e94
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSYa69489f7-4ffb-4cd1-b2d2-002f48e84f514
313782acetaminophen 325 MG Oral TabletPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
801092albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for VentolinPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
212033aspirin 325 MG Oral TabletPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1190552atropine sulfate 0.5 MG in 5 ML Prefilled SyringePSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1795514dextrose 50 % in 50 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
727517dextrose 50 % in 50 ML Prefilled SyringePSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
727373EPINEPHrine 1 MG in 10 ML Prefilled SyringePSN9ef8edbd-047a-40fe-a603-d71fce8ada683
797544isopropyl alcohol 70 % Medicated PadPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1737761lidocaine HCl 2 % in 5 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1012068lidocaine HCl 2 % in 5 ML Prefilled SyringePSN9ef8edbd-047a-40fe-a603-d71fce8ada683
198039nitroglycerin 0.4 MG Sublingual TabletPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
745752ProAir HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1807632sodium chloride 0.9 % in 100 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1807639sodium chloride 0.9 % in 1000 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1807627sodium chloride 0.9 % in 150 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1807630sodium chloride 0.9 % in 25 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1807633sodium chloride 0.9 % in 250 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1807631sodium chloride 0.9 % in 50 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
1807634sodium chloride 0.9 % in 500 ML InjectionPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
859088Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
801095Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 ActuationsPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
859088NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]SBD9ef8edbd-047a-40fe-a603-d71fce8ada683
801095NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]SBD9ef8edbd-047a-40fe-a603-d71fce8ada683
745752NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [ProAir]SBD9ef8edbd-047a-40fe-a603-d71fce8ada683
16600141 ML epinephrine 1 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
72737310 ML epinephrine 0.1 MG/ML Prefilled SyringeSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
1807632100 ML sodium chloride 9 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
18076391000 ML sodium chloride 9 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
1807627150 ML sodium chloride 9 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
180763025 ML sodium chloride 9 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
1807633250 ML sodium chloride 9 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
11905525 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
10120685 ML lidocaine hydrochloride 20 MG/ML Prefilled SyringeSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
179551450 ML glucose 500 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
72751750 ML glucose 500 MG/ML Prefilled SyringeSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
180763150 ML sodium chloride 9 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
1807634500 ML sodium chloride 9 MG/ML InjectionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
313782acetaminophen 325 MG Oral TabletSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
212033aspirin 325 MG Oral TabletSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
2123076NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
801092NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
2123072NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
198039nitroglycerin 0.4 MG Sublingual TabletSCD9ef8edbd-047a-40fe-a603-d71fce8ada683
1807632100 ML NaCl 9 MG/ML InjectionSY9ef8edbd-047a-40fe-a603-d71fce8ada683
18076391000 ML NaCl 9 MG/ML InjectionSY9ef8edbd-047a-40fe-a603-d71fce8ada683
1807627150 ML NaCl 9 MG/ML InjectionSY9ef8edbd-047a-40fe-a603-d71fce8ada683
745752200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose InhalerSY9ef8edbd-047a-40fe-a603-d71fce8ada683
180763025 ML NaCl 9 MG/ML InjectionSY9ef8edbd-047a-40fe-a603-d71fce8ada683
1807633250 ML NaCl 9 MG/ML InjectionSY9ef8edbd-047a-40fe-a603-d71fce8ada683
72751750 ML dextrose 50 % Prefilled SyringeSY9ef8edbd-047a-40fe-a603-d71fce8ada683
180763150 ML NaCl 9 MG/ML InjectionSY9ef8edbd-047a-40fe-a603-d71fce8ada683
1807634500 ML NaCl 9 MG/ML InjectionSY9ef8edbd-047a-40fe-a603-d71fce8ada683
801092albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose InhalerSY9ef8edbd-047a-40fe-a603-d71fce8ada683
801092albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose InhalerSY9ef8edbd-047a-40fe-a603-d71fce8ada683
2123072albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAirSY9ef8edbd-047a-40fe-a603-d71fce8ada683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3174-31000933174311 INHALER in 1 CARTON (0093-3174-31) / 200 AEROSOL, METERED in 1 INHALER1 inhaler2019-01-160000-00-00NoNoCurrent