FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
0378-8270
11-digit product format
003788270
Labeler code
0378
Product ID
0378-8270_6c181118-680f-4e62-b0d3-057a14803a4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA077839
Marketing category
ANDA
Marketing start
2012-10-15
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/3mL
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2.5 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
36390b75-5438-47d3-af60-732a654e9025Product name220220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-8270-31Albuterol Sulfate1 in 1 POUCHSOLUTION13
0378-8270-31Albuterol Sulfate3 mL in 1 AMPULESOLUTION33
0378-8270-52Albuterol Sulfate1 in 1 CARTONSOLUTION13
0378-8270-55Albuterol Sulfate30 in 1 CARTONSOLUTION303
0378-8270-62Albuterol Sulfate3 mL in 1 AMPULESOLUTION33
0378-8270-62Albuterol Sulfate25 in 1 POUCHSOLUTION253
0378-8270-64Albuterol Sulfate30 in 1 POUCHSOLUTION303
0378-8270-64Albuterol Sulfate3 mL in 1 AMPULESOLUTION33
0378-8270-91Albuterol Sulfate2 in 1 CARTONSOLUTION23
0378-8270-93Albuterol Sulfate1 in 1 CARTONSOLUTION13
0378-8270-93Albuterol Sulfate30 in 1 POUCHSOLUTION303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-8270-31ML - Milliliter0378-827013a84a99-d007-406f-82f9-9bd10cf3e82c12019-08-06
0378-8270-52ML - Milliliter0378-8270f881d9eb-9bba-4ded-88d6-c4ed39e51bea12013-02-13
0378-8270-55ML - Milliliter0378-827081e12293-d420-4036-8dcc-93a8b7921a7a12014-04-03
0378-8270-62ML - Milliliter0378-82703f67c08e-ab58-474d-8627-4512c1bb3c8512015-11-12
0378-8270-64ML - Milliliter0378-82700589cfda-a444-4b3c-a71c-16797f4228f612019-08-06
0378-8270-91ML - Milliliter0378-8270824f79e0-b2be-4d08-86bd-c54ee5e0643512013-05-02
0378-8270-93ML - Milliliter0378-827052e4fd80-3f56-4b72-a072-2fc26bcc67eb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albuterol SulfateACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2
AlbuterolACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2
Sulfuric AcidINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-8270ALBUTEROL SULFATE SOLUTION [MYLAN PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 11 package rows20190510_5329614f-ae0b-4854-bb6f-ea0b7dae87c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSNc90e80b2-882e-4c0c-bfac-d67eb1da724d4
630208albuterol 0.83 MG/ML Inhalation SolutionSCDc90e80b2-882e-4c0c-bfac-d67eb1da724d4
630208albuterol 0.083 % Inhalation SolutionSYc90e80b2-882e-4c0c-bfac-d67eb1da724d4
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYc90e80b2-882e-4c0c-bfac-d67eb1da724d4
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYc90e80b2-882e-4c0c-bfac-d67eb1da724d4
630208albuterol sulfate 0.083 % Inhalation SolutionPSN5329614f-ae0b-4854-bb6f-ea0b7dae87c03
630208albuterol 0.83 MG/ML Inhalation SolutionSCD5329614f-ae0b-4854-bb6f-ea0b7dae87c03
630208albuterol 0.083 % Inhalation SolutionSY5329614f-ae0b-4854-bb6f-ea0b7dae87c03
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY5329614f-ae0b-4854-bb6f-ea0b7dae87c03
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY5329614f-ae0b-4854-bb6f-ea0b7dae87c03
630208albuterol sulfate 0.083 % Inhalation SolutionPSN1ebb48dd-e747-781b-e063-6294a90a633b1
630208albuterol 0.83 MG/ML Inhalation SolutionSCD1ebb48dd-e747-781b-e063-6294a90a633b1
630208albuterol 0.083 % Inhalation SolutionSY1ebb48dd-e747-781b-e063-6294a90a633b1
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY1ebb48dd-e747-781b-e063-6294a90a633b1
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY1ebb48dd-e747-781b-e063-6294a90a633b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-8270-31003788270311 in 1 POUCHHistorical
0378-8270-52003788270521 POUCH in 1 CARTON (0378-8270-52) / 25 AMPULE in 1 POUCH (0378-8270-62) / 3 mL in 1 AMPULE1 pouch2012-12-180000-00-00NoNoCurrent
0378-8270-550037882705530 POUCH in 1 CARTON (0378-8270-55) / 1 AMPULE in 1 POUCH (0378-8270-31) / 3 mL in 1 AMPULE30 pouch2014-03-060000-00-00NoNoCurrent
0378-8270-62003788270623 mL in 1 AMPULE3 mlHistorical
0378-8270-640037882706430 in 1 POUCHHistorical
0378-8270-91003788270912 POUCH in 1 CARTON (0378-8270-91) / 30 AMPULE in 1 POUCH (0378-8270-64) / 3 mL in 1 AMPULE2 pouch2013-04-110000-00-00NoNoCurrent
0378-8270-93003788270931 POUCH in 1 CARTON (0378-8270-93) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE1 pouch2013-01-220000-00-00NoNoCurrent