ALBUTEROL SULFATE

Product NDC
70518-4490
11-digit product format
705184490
Labeler code
70518
Product ID
70518-4490_407d27eb-478a-0456-e063-6294a90ac3a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALBUTEROL SULFATE
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
REMEDYREPACK INC.
Application
ANDA206224
Marketing category
ANDA
Marketing start
2025-10-03
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
021SEF3731ALBUTEROL SULFATE51022-70-9ALBUTEROL SULFATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4490-0705184490005 POUCH in 1 CARTON (70518-4490-0) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE5 pouch2025-10-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Albuterol Sulfate Inhalation Solution 0.083%*REMEDYREPACK INC.2025-10-06HUMAN PRESCRIPTION DRUG LABEL1