FDA.reportPublic FDA data

Albuterol

Product NDC
21695-198
11-digit product format
216950198
Labeler code
21695
Product ID
21695-198_29d24a6d-f9c1-4300-97c7-fec26bdbc22b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol
Dosage form
AEROSOL, METERED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA072273
Marketing category
ANDA
Marketing start
1996-08-14
Marketing end
0000-00-00
Substance
ALBUTEROL
Active strength
90 ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-198-012019-09-24C16284748780-1934fe258-4c56-48b1-e053-8cdaa90a720aAlbuterol Inhalation Aerosol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-198-01Albuterol200 in 1 CANISTERAEROSOL, METERED2001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AlbuterolACTIVE INGREDIENTQF8SVZ843EALBUTEROL AEROSOL, METERED [REBEL DISTRIBUTORS CORP]1
AlbuterolACTIVE MOIETYQF8SVZ843EALBUTEROL AEROSOL, METERED [REBEL DISTRIBUTORS CORP]1
dichlorofluoromethaneINACTIVE INGREDIENT7GAO4CRJ0BALBUTEROL AEROSOL, METERED [REBEL DISTRIBUTORS CORP]1
oleic acidINACTIVE INGREDIENT2UMI9U37CPALBUTEROL AEROSOL, METERED [REBEL DISTRIBUTORS CORP]1
TRICHLOROMONOFLUOROMETHANEINACTIVE INGREDIENT990TYB331RALBUTEROL AEROSOL, METERED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-198ALBUTEROL AEROSOL, METERED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110722_29d24a6d-f9c1-4300-97c7-fec26bdbc22b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
745679albuterol sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN29d24a6d-f9c1-4300-97c7-fec26bdbc22b1
745679200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD29d24a6d-f9c1-4300-97c7-fec26bdbc22b1
745679albuterol 0.09 MG/ACTUAT 200 ACTUAT Metered Dose InhalerSY29d24a6d-f9c1-4300-97c7-fec26bdbc22b1
745679albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 200 ACTUAT Metered Dose InhalerSY29d24a6d-f9c1-4300-97c7-fec26bdbc22b1
745679albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY29d24a6d-f9c1-4300-97c7-fec26bdbc22b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-198-0121695019801200 in 1 CANISTERHistorical