Levalbuterol Inhalation Solution

Product NDC
16714-095
11-digit product format
167140095
Labeler code
16714
Product ID
16714-095_a60ea366-65a8-4559-9af5-5afd97875d2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol Inhalation Solution
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
NorthStar RxLLC
Application
ANDA207820
Marketing category
ANDA
Marketing start
2020-05-05
Marketing end
0000-00-00
Substance
LEVALBUTEROL HYDROCHLORIDE
Active strength
1 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-095-05ML - Milliliter16714-095e2280cb6-60c9-4c4d-be41-146fa6b0904512023-03-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-095-25167140095255 POUCH in 1 CARTON (16714-095-25) > 5 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE5 pouch2020-05-050000-00-00NoNoCurrent