Levalbuterol
- Product NDC
- 0093-4147
- 11-digit product format
- 000934147
- Labeler code
- 0093
- Product ID
- 0093-4147_9991cb94-c878-4ec9-aacd-8a2534ac60c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levalbuterol
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA200875
- Marketing category
- ANDA
- Marketing start
- 2014-12-16
- Marketing end
- 0000-00-00
- Substance
- LEVALBUTEROL HYDROCHLORIDE
- Active strength
- 1 mg/.5mL
- 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 | 0093-4147 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0093-4147 | 0093-4147-56 | 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 |
|---|
| A200875-001 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.25% BASE | SOLUTION / INHALATION | AN | | 2014-09-11 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A200875-001 | AN |
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 |
|---|
| 0093-4147-56 | 00093414756 | 30 POUCH in 1 CARTON (0093-4147-56) > 1 VIAL, SINGLE-DOSE in 1 POUCH (0093-4147-19) > .5 mL in 1 VIAL, SINGLE-DOSE | 30 pouch | 2014-12-16 | 0000-00-00 | No | No | Current |