Albuterol Sulfate

Product NDC
0378-6992
11-digit product format
003786992
Labeler code
0378
Product ID
0378-6992_7b27e883-eb0c-4415-83f5-f19b16168d6f
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
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6992-52ML - Milliliter0378-6992c8dd0cfd-84cb-4d40-8413-df69cf3a24a612012-07-24
0378-6992-98ML - Milliliter0378-69928997d909-fcdc-4b94-8cd3-3f1dbf0d263412020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-6992-52003786992525 POUCH in 1 CARTON (0378-6992-52) > 5 VIAL in 1 POUCH (0378-6992-98) > 3 mL in 1 VIAL5 pouch2009-10-300000-00-00NoNoCurrent