Levalbuterol
- Product NDC
- 50090-6377
- 11-digit product format
- 500906377
- Labeler code
- 50090
- Product ID
- 50090-6377_9c6c8e7b-61bd-437b-ba6e-cb394ad19d16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levalbuterol Hydrochloride
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- A-S Medication Solutions
- Application
- ANDA203653
- Marketing category
- ANDA
- Marketing start
- 2021-04-01
- Substance
- LEVALBUTEROL HYDROCHLORIDE
- Active strength
- .63 mg/3mL
- 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 | .63 mg/3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WDQ1526QJM |
| Rxcui | 311286 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-6377-0 | Levalbuterol | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 50090-6377-0 | Levalbuterol | 25 mL in 1 POUCH | SOLUTION | 25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6377 | LEVALBUTEROL (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [A-S MEDICATION SOLUTIONS] | 2 | Current NDC, 2 package rows | 20230301_262c0b8b-8461-4bdf-b272-c829d33fd451.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6377-0 | 50090637700 | 1 POUCH in 1 CARTON (50090-6377-0) / 25 mL in 1 POUCH | 1 pouch | 2023-02-20 | No | No | Current |