FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
71205-641
11-digit product format
712050641
Labeler code
71205
Product ID
71205-641_4263a4e9-a9d9-40da-ad2c-c75c82976319
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Proficient Rx LP
Application
ANDA207857
Marketing category
ANDA
Marketing start
2021-06-11
Substance
ALBUTEROL SULFATE
Active strength
.83 mg/mL
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
Albuterol Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE.83 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui630208

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
71205-641-25Albuterol Sulfate5 in 1 POUCHSOLUTION53
71205-641-25Albuterol Sulfate5 in 1 CARTONSOLUTION53
71205-641-30Albuterol Sulfate6 in 1 CARTONSOLUTION63
71205-641-30Albuterol Sulfate5 in 1 POUCHSOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-641ALBUTEROL SULFATE SOLUTION [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20250413_a6545fbe-b0a6-41ae-8bb6-91af38410f56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSNa6545fbe-b0a6-41ae-8bb6-91af38410f563
630208albuterol 0.83 MG/ML Inhalation SolutionSCDa6545fbe-b0a6-41ae-8bb6-91af38410f563
630208albuterol 0.083 % Inhalation SolutionSYa6545fbe-b0a6-41ae-8bb6-91af38410f563
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYa6545fbe-b0a6-41ae-8bb6-91af38410f563
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYa6545fbe-b0a6-41ae-8bb6-91af38410f563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-641-25712050641255 POUCH in 1 CARTON (71205-641-25) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL5 pouch2022-02-250000-00-00NoNoCurrent
71205-641-30712050641306 POUCH in 1 CARTON (71205-641-30) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL6 pouch2025-04-08NoNoCurrent