Levalbuterol
- Product NDC
- 0378-6993
- 11-digit product format
- 003786993
- Labeler code
- 0378
- Product ID
- 0378-6993_0aa39730-fc51-4088-8955-b11aac3025d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levalbuterol
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA078309
- Marketing category
- ANDA
- Marketing start
- 2009-08-28
- Substance
- LEVALBUTEROL HYDROCHLORIDE
- Active strength
- 1.25 mg/.5mL
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levalbuterol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVALBUTEROL HYDROCHLORIDE | 1.25 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WDQ1526QJM |
| Rxcui | 1855389 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-6993-31 | Levalbuterol | 1 in 1 POUCH | SOLUTION, CONCENTRATE | 1 | | 15 |
| 0378-6993-31 | Levalbuterol | .5 mL in 1 VIAL | SOLUTION, CONCENTRATE | .5 | | 15 |
| 0378-6993-93 | Levalbuterol | 30 in 1 CARTON | SOLUTION, CONCENTRATE | 30 | | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-6993 | LEVALBUTEROL SOLUTION, CONCENTRATE [MYLAN PHARMACEUTICALS INC.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20191123_206bbdec-04f0-40e3-a259-32fc6bce20d8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-6993-31 | 00378699331 | 1 in 1 POUCH | | | | | | Historical |
| 0378-6993-93 | 00378699393 | 30 POUCH in 1 CARTON (0378-6993-93) / 1 VIAL in 1 POUCH (0378-6993-31) / .5 mL in 1 VIAL | 30 pouch | 2009-08-28 | 0000-00-00 | No | No | Current |