FDA.reportPublic FDA data

Levalbuterol Inhalation Solution

Product NDC
16714-095
Requested package NDC
16714-095-25
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16714-09516714-095-25DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207820-001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATION2018-11-05
A207820-002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATION2018-11-05
A207820-003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATION2018-11-05

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207820-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATION2018-11-05a50c72e98297…
2026-08-01 22:54:322026-06A207820-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATION2018-11-05a50c72e98297…
2026-08-01 22:54:322026-06A207820-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATION2018-11-05a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levalbuterol Inhalation SolutionLEVALBUTEROL INHALATION SOLUTIONSun Pharmaceutical Industries, Inc.85a59e0c-ff09-49a6-b7b8-616e033107b42020-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207820
application number: ANDA207820

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