Albuterol Sulfate

Product NDC
0378-6991
11-digit product format
003786991
Labeler code
0378
Product ID
0378-6991_6dffeffb-517b-4a6d-ae20-d5b7a22ff131
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albuterol sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020949
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-10-30
Marketing end
2023-06-01
Substance
ALBUTEROL SULFATE
Active strength
1 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6991-52ML - Milliliter0378-69915150eaa0-3a89-4d1c-bf2c-185d0bf1043b12012-07-24
0378-6991-98ML - Milliliter0378-69917c449dc1-7fd9-4e6c-8bcf-5733033c6c7612022-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-6991-52003786991525 POUCH in 1 CARTON (0378-6991-52) > 5 VIAL in 1 POUCH (0378-6991-98) > 3 mL in 1 VIAL5 pouch2009-10-300000-00-00NoNoCurrent