Levalbuterol
- Product NDC
- 0378-9680
- 11-digit product format
- 003789680
- Labeler code
- 0378
- Product ID
- 0378-9680_111e97b2-4366-4552-8bf8-c2f944fd317e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levalbuterol
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA077800
- Marketing category
- ANDA
- Marketing start
- 2013-03-15
- Marketing end
- 2019-08-31
- 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
- 0000-00-00
- 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 | 0378-9680 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0378-9680 | 0378-9680-44 | 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 |
|---|
| A077800-001 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.0103% BASE | SOLUTION / INHALATION | | | 2013-03-15 |
| A077800-002 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.021% BASE | SOLUTION / INHALATION | | | 2013-03-15 |
| A077800-003 | LEVALBUTEROL HYDROCHLORIDE | LEVALBUTEROL HYDROCHLORIDE | EQ 0.042% BASE | SOLUTION / INHALATION | | | 2013-03-15 |