FDA.reportPublic FDA data

Levalbuterol

Product NDC
68788-6777
11-digit product format
687886777
Labeler code
68788
Product ID
68788-6777_a9959bc1-e5e6-46e7-be8d-bd2865b3a05e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levalbuterol
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA090297
Marketing category
ANDA
Marketing start
2016-10-24
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
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-6777DDiscontinued by firm2026-07-31
excluded packagepackage68788-677768788-6777-2DDiscontinued 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
A090297-001LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26
A090297-002LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26
A090297-003LEVALBUTEROL HYDROCHLORIDELEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090297-001AN
A090297-002AN
A090297-003AN

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 22:54:322026-06A090297-001LEVALBUTEROL HYDROCHLORIDEEQ 0.0103% BASESOLUTION / INHALATIONANRS2013-04-26a50c72e98297…
2026-08-01 22:54:322026-06A090297-002LEVALBUTEROL HYDROCHLORIDEEQ 0.021% BASESOLUTION / INHALATIONANRS2013-04-26a50c72e98297…
2026-08-01 22:54:322026-06A090297-003LEVALBUTEROL HYDROCHLORIDEEQ 0.042% BASESOLUTION / INHALATIONANRS2013-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090297-001AN1a50c72e98297…
2026-08-01 22:54:322026-06A090297-002AN1a50c72e98297…
2026-08-01 22:54:322026-06A090297-003AN1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevalbuterolLEVALBUTEROLProficient Rx LP97699821-81f8-4623-8504-e479c0f4b1832019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090297
application number: ANDA090297
LevalbuterolLEVALBUTEROLTeva Pharmaceuticals USA, Inc.f3ce78d9-e923-400e-b3cd-3e6124ac7f6d2019-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090297
application number: ANDA090297