FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
50383-740
11-digit product format
503830740
Labeler code
50383
Product ID
50383-740_8286f8f0-8267-4502-adf0-c15d47d6ad7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SYRUP
Route
ORAL
Labeler
Akorn
Application
ANDA074749
Marketing category
ANDA
Marketing start
1998-01-30
Marketing end
0000-00-00
Substance
ALBUTEROL SULFATE
Active strength
2 mg/5mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
36390b75-5438-47d3-af60-732a654e9025Product name220220110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-740-162024-01-30C16284748780-11030e365-5326-111a-e063-dadaa90a10e2ALBUTEROL SULFATE SYRUP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-740-16Albuterol Sulfate473 mL in 1 BOTTLESYRUP4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-740-16ML - Milliliter50383-74045257b16-a0d0-4994-b90e-4c52e87d2cfc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ORANGEINACTIVE INGREDIENT5EVU04N5QUALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
ORANGEINACTIVE INGREDIENT5EVU04N5QUALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ORANGEINACTIVE INGREDIENT5EVU04N5QUALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
SACCHARININACTIVE INGREDIENTFST467XS7DALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
SACCHARININACTIVE INGREDIENTFST467XS7DALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
SACCHARININACTIVE INGREDIENTFST467XS7DALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SYRUP [DISPENSING SOLUTIONS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SYRUP [HI-TECH PHARMACAL CO., INC.]2
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
SACCHARININACTIVE INGREDIENTFST467XS7DALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SYRUP [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-740ALBUTEROL SULFATE SYRUP [AKORN]6Legacy NDC, 1 package rows20221103_d3544356-e36a-4ce6-8235-cb0531c658ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSNd3544356-e36a-4ce6-8235-cb0531c658ad6
755497albuterol 0.4 MG/ML Oral SolutionSCDd3544356-e36a-4ce6-8235-cb0531c658ad6
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSYd3544356-e36a-4ce6-8235-cb0531c658ad6
755497albuterol 2 MG per 5 ML SyrupSYd3544356-e36a-4ce6-8235-cb0531c658ad6
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSNe21e3867-d156-495b-b8b2-36ad813775fa4
755497albuterol 0.4 MG/ML Oral SolutionSCDe21e3867-d156-495b-b8b2-36ad813775fa4
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSYe21e3867-d156-495b-b8b2-36ad813775fa4
755497albuterol 2 MG per 5 ML SyrupSYe21e3867-d156-495b-b8b2-36ad813775fa4
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN8d215fe3-1cf6-4bb3-b005-75f1a9d622352
755497albuterol 0.4 MG/ML Oral SolutionSCD8d215fe3-1cf6-4bb3-b005-75f1a9d622352
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY8d215fe3-1cf6-4bb3-b005-75f1a9d622352
755497albuterol 2 MG per 5 ML SyrupSY8d215fe3-1cf6-4bb3-b005-75f1a9d622352
755497albuterol sulfate 2 MG in 5 mL Oral SolutionPSN071e819b-43cd-48f7-b63e-c891936dcfc41
755497albuterol 0.4 MG/ML Oral SolutionSCD071e819b-43cd-48f7-b63e-c891936dcfc41
755497albuterol (as albuterol sulfate) 2 MG per 5 ML SyrupSY071e819b-43cd-48f7-b63e-c891936dcfc41
755497albuterol 2 MG per 5 ML SyrupSY071e819b-43cd-48f7-b63e-c891936dcfc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-740-1650383074016473 mL in 1 BOTTLE (50383-740-16) 473 ml1998-01-300000-00-00NoNoCurrent