FDA.reportPublic FDA data

Albuterol Sulfate Inhalation Solution, 0.5%

Product NDC
76204-027
11-digit product format
762040027
Labeler code
76204
Product ID
76204-027_4e7f86ab-55bc-c123-e063-6394a90abd8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
Application
ANDA218386
Marketing category
ANDA
Marketing start
2025-03-24
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/.5mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate Inhalation Solution, 0.5%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2.5 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui245314

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76204-027-01Albuterol Sulfate Inhalation Solution, 0.5%30 in 1 CARTONSOLUTION304
76204-027-11Albuterol Sulfate Inhalation Solution, 0.5%1 in 1 POUCHSOLUTION14
76204-027-11Albuterol Sulfate Inhalation Solution, 0.5%0.5 mL in 1 VIALSOLUTION0.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-027-01EA - Each76204-027c84d29b7-3e26-4f71-9952-cbfb7bfa761912025-05-14
76204-027-11EA - Each76204-027c2b8b7c1-d312-41bf-a17e-a122a8a9884612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-027ALBUTEROL SULFATE INHALATION SOLUTION, 0.5% (ALBUTEROL SULFATE) SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]2Current NDC, 3 package rows20250326_fdb4ac5a-bf0d-4896-89f7-1828c081b79e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245314albuterol 0.5 % Inhalation SolutionPSNfdb4ac5a-bf0d-4896-89f7-1828c081b79e4
245314albuterol 5 MG/ML Inhalation SolutionSCDfdb4ac5a-bf0d-4896-89f7-1828c081b79e4
245314albuterol (as albuterol sulfate) 5 MG/ML Inhalation SolutionSYfdb4ac5a-bf0d-4896-89f7-1828c081b79e4
245314albuterol 0.5 % Concentrate for Inhalation SolutionSYfdb4ac5a-bf0d-4896-89f7-1828c081b79e4
245314albuterol 1 MG/ML (concentrate 0.5 % ) Inhalation SolutionSYfdb4ac5a-bf0d-4896-89f7-1828c081b79e4
245314albuterol 1 MG/ML (concentrate 5 MG/ML) Inhalation SolutionSYfdb4ac5a-bf0d-4896-89f7-1828c081b79e4
245314albuterol 2.5 MG per 0.5 ML Concentrate for Inhalation SolutionSYfdb4ac5a-bf0d-4896-89f7-1828c081b79e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76204-027-017620400270130 POUCH in 1 CARTON (76204-027-01) / 1 VIAL in 1 POUCH (76204-027-11) / .5 mL in 1 VIAL30 pouch2025-03-24NoNoCurrent
76204-027-11762040027111 in 1 POUCHHistorical