Levalbuterol Hydrochloride
- Product NDC
- 66993-021
- 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
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 66993-021 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 66993-021 | 66993-021-27 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
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| LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | | RLD | 1999-03-25 |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| LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | | RLD | 1999-03-25 |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| LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | | RLD | 2002-01-30 |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| LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INHALATION | | RLD | 2003-07-18 |
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 |