FDA.reportPublic FDA data

Levalbuterol

Product NDC
35573-445
11-digit product format
355730445
Labeler code
35573
Product ID
35573-445_0639bb69-d41d-4786-af70-797c452fbbfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol Hydrochloride
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Burel Pharmaceuticals, LLC
Application
ANDA203653
Marketing category
ANDA
Marketing start
2021-04-01
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
1.25 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 HYDROCHLORIDE1.25 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
35573-445-25Levalbuterol25 in 1 CARTONSOLUTION259
35573-445-25Levalbuterol25 in 1 POUCHSOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-445-25ML - Milliliter35573-445e3eb4d08-be9b-464a-a6fb-da3bb40c7df512021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-445LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [BUREL PHARMACEUTICALS, LLC]9Current NDC, Legacy NDC, 2 package rows20230613_737fe40b-798b-4d7f-bec9-7af952018ab5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSN737fe40b-798b-4d7f-bec9-7af952018ab59
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSN737fe40b-798b-4d7f-bec9-7af952018ab59
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSN737fe40b-798b-4d7f-bec9-7af952018ab59
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCD737fe40b-798b-4d7f-bec9-7af952018ab59
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCD737fe40b-798b-4d7f-bec9-7af952018ab59
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCD737fe40b-798b-4d7f-bec9-7af952018ab59
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSY737fe40b-798b-4d7f-bec9-7af952018ab59
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSY737fe40b-798b-4d7f-bec9-7af952018ab59
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSY737fe40b-798b-4d7f-bec9-7af952018ab59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35573-445-253557304452525 POUCH in 1 CARTON (35573-445-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE25 pouch2021-04-010000-00-00NoNoCurrent