Home NDC 66993-021-27 Levalbuterol Hydrochloride
Product NDC 66993-021
Requested package NDC 66993-021-27
11-digit product format 669930021
Labeler code 66993
Product ID 66993-021_86d089a7-afc9-44e7-8b65-439e8466568a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levalbuterol Hydrochloride
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Prasco Laboratories
Application NDA020837
Marketing category NDA
Marketing start 2015-02-27
Marketing end 0000-00-00
Substance LEVALBUTEROL HYDROCHLORIDE
Active strength 0 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020837-001 XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 1999-03-25 N020837-002 XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 1999-03-25 N020837-003 XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2002-01-30 N020837-004 XOPENEX LEVALBUTEROL HYDROCHLORIDE EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2003-07-18
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N020837-001 XOPENEX EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 1999-03-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N020837-002 XOPENEX EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 1999-03-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N020837-003 XOPENEX EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2002-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N020837-004 XOPENEX EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INHALATION RLD 2003-07-18 a50c72e98297…
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66993-021-27 66993002127 2 POUCH in 1 CARTON (66993-021-27) > 12 VIAL, SINGLE-DOSE in 1 POUCH (66993-021-35) > 3 mL in 1 VIAL, SINGLE-DOSE 2 pouch 2015-02-27 0000-00-00 No No Current