FDA.reportPublic FDA data

Levalbuterol tartrate HFA inhalation

Product NDC
63187-876
11-digit product format
631870876
Labeler code
63187
Product ID
63187-876_a790bb9c-91e9-4231-a093-4d3edbaf94fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levalbuterol tartrate
Dosage form
AEROSOL, METERED
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021730
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-10-01
Substance
LEVALBUTEROL TARTRATE
Active strength
45 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
Levalbuterol tartrate HFA inhalation
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVALBUTEROL TARTRATE45 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiADS4I3E22M
Rxcui745791

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b93cc5d-8105-47d8-8ae6-077d0f655880Product name320190213
415a13b7-458d-4b44-ab20-f56d8ef7ab9dProduct name220170426
a511b237-73ca-80ef-2a42-a935d09028adProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-876-15Levalbuterol tartrate HFA inhalation200 in 1 INHALERAEROSOL, METERED2004
63187-876-15Levalbuterol tartrate HFA inhalation1 in 1 CARTONAEROSOL, METERED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-876-15GM - Gram63187-876dc28fa19-a93e-4fec-be17-abd5871ae17112017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-876LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE) AEROSOL, METERED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20221202_a469689a-e64e-4117-b94a-c8b730abda1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
745791levalbuterol 45 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNa469689a-e64e-4117-b94a-c8b730abda1a4
745791200 ACTUAT levalbuterol 0.045 MG/ACTUAT Metered Dose InhalerSCDa469689a-e64e-4117-b94a-c8b730abda1a4
745791levalbuterol 0.045 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYa469689a-e64e-4117-b94a-c8b730abda1a4
745791levalbuterol 45 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYa469689a-e64e-4117-b94a-c8b730abda1a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-876-15631870876151 INHALER in 1 CARTON (63187-876-15) / 200 AEROSOL, METERED in 1 INHALER1 inhaler2017-08-010000-00-00NoNoCurrent