FDA.reportPublic FDA data

Levalbuterol

Product NDC
76204-700
11-digit product format
762040700
Labeler code
76204
Product ID
76204-700_459fa0f5-35d9-d6e5-e063-6394a90a6f14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol Hydrochloride
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
Application
ANDA203653
Marketing category
ANDA
Marketing start
2016-03-22
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
76204-700-01Levalbuterol30 in 1 CARTONSOLUTION3022
76204-700-05Levalbuterol5 in 1 POUCHSOLUTION522
76204-700-05Levalbuterol3 mL in 1 AMPULESOLUTION322
76204-700-11Levalbuterol1 in 1 POUCHSOLUTION122
76204-700-11Levalbuterol3 mL in 1 AMPULESOLUTION322
76204-700-15Levalbuterol25 in 1 POUCHSOLUTION2522
76204-700-15Levalbuterol3 mL in 1 AMPULESOLUTION322
76204-700-25Levalbuterol1 in 1 CARTONSOLUTION122
76204-700-55Levalbuterol5 in 1 CARTONSOLUTION522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-700-01ML - Milliliter76204-700e2a8782d-232f-4a8e-9a79-d58b273c448112017-07-07
76204-700-11ML - Milliliter76204-700ea685b17-0883-481c-92f7-09358a5c50cb12017-07-07
76204-700-12ML - Milliliter76204-7008ca0bd95-1cfb-472a-bb1b-fab9fa661c9612016-05-16
76204-700-15ML - Milliliter76204-700455528ba-d54e-46a9-93f2-3cbb25107c8512017-08-11
76204-700-24ML - Milliliter76204-70029315b00-e821-41f3-94bb-c376097dd55312016-05-16
76204-700-25ML - Milliliter76204-70088414cf9-36f4-45a6-ad02-6c34802efcac12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-700LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]20Current NDC, Legacy NDC, 9 package rows20241219_d6998949-e1cb-4c86-a480-c0dfd9cb75b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349590levalbuterol HCl 0.31 MG in 3 ML Inhalation SolutionPSNd6998949-e1cb-4c86-a480-c0dfd9cb75b522
311286levalbuterol HCl 0.63 MG in 3 ML Inhalation SolutionPSNd6998949-e1cb-4c86-a480-c0dfd9cb75b522
242754levalbuterol HCl 1.25 MG in 3 ML Inhalation SolutionPSNd6998949-e1cb-4c86-a480-c0dfd9cb75b522
349590levalbuterol 0.103 MG/ML Inhalation SolutionSCDd6998949-e1cb-4c86-a480-c0dfd9cb75b522
311286levalbuterol 0.21 MG/ML Inhalation SolutionSCDd6998949-e1cb-4c86-a480-c0dfd9cb75b522
242754levalbuterol 0.417 MG/ML Inhalation SolutionSCDd6998949-e1cb-4c86-a480-c0dfd9cb75b522
349590levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation SolutionSYd6998949-e1cb-4c86-a480-c0dfd9cb75b522
311286levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation SolutionSYd6998949-e1cb-4c86-a480-c0dfd9cb75b522
242754levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation SolutionSYd6998949-e1cb-4c86-a480-c0dfd9cb75b522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76204-700-017620407000130 POUCH in 1 CARTON (76204-700-01) / 1 AMPULE in 1 POUCH (76204-700-11) / 3 mL in 1 AMPULE30 pouch2017-02-170000-00-00NoNoCurrent
76204-700-05762040700055 in 1 POUCHHistorical
76204-700-11762040700111 in 1 POUCHHistorical
76204-700-157620407001525 in 1 POUCHHistorical
76204-700-25762040700251 POUCH in 1 CARTON (76204-700-25) / 25 AMPULE in 1 POUCH (76204-700-15) / 3 mL in 1 AMPULE1 pouch2017-02-170000-00-00NoNoCurrent
76204-700-55762040700555 POUCH in 1 CARTON (76204-700-55) / 5 AMPULE in 1 POUCH (76204-700-05) / 3 mL in 1 AMPULE5 pouch2017-02-170000-00-00NoNoCurrent