FDA.reportPublic FDA data

Levalbuterol

Product NDC
0115-9931
11-digit product format
001159931
Labeler code
0115
Product ID
0115-9931_be1c7c11-31c8-4e84-bf0a-e395f0a21485
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol Hydrochloride
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA203653
Marketing category
ANDA
Marketing start
2016-03-22
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
.63 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.63 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-9931-782023-02-03C16284748780-1f386c649-c802-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx only
0115-9931-782023-01-30C16284748780-1f386c649-c802-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-9931-76Levalbuterol3 mL in 1 AMPULESOLUTION35
0115-9931-76Levalbuterol25 in 1 POUCHSOLUTION255
0115-9931-78Levalbuterol1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-9931-76ML - Milliliter0115-9931d27a3ad9-7657-4a3b-9d8c-6f8a71a529e112018-03-08
0115-9931-78ML - Milliliter0115-99311af790f2-859a-4787-b3aa-b1ddbc58b00b12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-9931LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]5Current NDC, Legacy NDC, 3 package rows20230204_e5c8368a-49f9-45cf-9d42-a871f005edb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSNd4080fc5-50d6-49a9-8a63-7769d201968d100
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCDd4080fc5-50d6-49a9-8a63-7769d201968d100
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSYd4080fc5-50d6-49a9-8a63-7769d201968d100
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSNe5c8368a-49f9-45cf-9d42-a871f005edb95
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSNe5c8368a-49f9-45cf-9d42-a871f005edb95
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSNe5c8368a-49f9-45cf-9d42-a871f005edb95
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCDe5c8368a-49f9-45cf-9d42-a871f005edb95
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCDe5c8368a-49f9-45cf-9d42-a871f005edb95
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCDe5c8368a-49f9-45cf-9d42-a871f005edb95
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSYe5c8368a-49f9-45cf-9d42-a871f005edb95
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSYe5c8368a-49f9-45cf-9d42-a871f005edb95
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSYe5c8368a-49f9-45cf-9d42-a871f005edb95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-9931-76001159931763 mL in 1 AMPULE3 mlHistorical
0115-9931-78001159931781 POUCH in 1 CARTON (0115-9931-78) / 25 AMPULE in 1 POUCH (0115-9931-76) / 3 mL in 1 AMPULE1 pouch2017-02-170000-00-00NoNoCurrent