FDA.reportPublic FDA data

Levalbuterol

Product NDC
0378-9690
11-digit product format
003789690
Labeler code
0378
Product ID
0378-9690_2f82efe7-5a39-44e6-a7c0-840a60c6246f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA203653
Marketing category
ANDA
Marketing start
2018-07-23
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
.31 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
Levalbuterol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVALBUTEROL HYDROCHLORIDE.31 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWDQ1526QJM
Rxcui242754, 311286, 349590

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
0378-9690-52Levalbuterol1 in 1 CARTONSOLUTION14
0378-9690-62Levalbuterol3 mL in 1 AMPULESOLUTION34
0378-9690-62Levalbuterol25 in 1 POUCHSOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9690-52ML - Milliliter0378-9690d60844c6-dd07-41c2-8bf4-6395dfbab13f12018-08-13
0378-9690-62ML - Milliliter0378-96902afe9b04-2e0a-4f5f-a095-3a4cfa783f0f12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9690LEVALBUTEROL SOLUTION [MYLAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20200422_5b4fa89e-aa46-4504-a275-246f3b4df1df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSN5b4fa89e-aa46-4504-a275-246f3b4df1df4
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSN5b4fa89e-aa46-4504-a275-246f3b4df1df4
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSN5b4fa89e-aa46-4504-a275-246f3b4df1df4
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCD5b4fa89e-aa46-4504-a275-246f3b4df1df4
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCD5b4fa89e-aa46-4504-a275-246f3b4df1df4
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCD5b4fa89e-aa46-4504-a275-246f3b4df1df4
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSY5b4fa89e-aa46-4504-a275-246f3b4df1df4
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSY5b4fa89e-aa46-4504-a275-246f3b4df1df4
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSY5b4fa89e-aa46-4504-a275-246f3b4df1df4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9690-52003789690521 POUCH in 1 CARTON (0378-9690-52) / 25 AMPULE in 1 POUCH (0378-9690-62) / 3 mL in 1 AMPULE1 pouch2018-07-230000-00-00NoNoCurrent
0378-9690-62003789690623 mL in 1 AMPULE3 mlHistorical