Levalbuterol
- Product NDC
- 63187-953
- 11-digit product format
- 631870953
- Labeler code
- 63187
- Product ID
- 63187-953_efb4df4c-19c2-4c42-bf10-d1613186db7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levalbuterol
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Proficient Rx LP
- Application
- ANDA090297
- Marketing category
- ANDA
- Marketing start
- 2013-04-29
- 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 |
|---|
| 63187-953-24 | Levalbuterol | 3 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 3 | | 3 |
| 63187-953-24 | Levalbuterol | 24 in 1 CARTON | SOLUTION | 24 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-953 | LEVALBUTEROL SOLUTION [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 2 package rows | 20191122_97699821-81f8-4623-8504-e479c0f4b183.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-953-24 | 63187095324 | 24 VIAL, SINGLE-DOSE in 1 CARTON (63187-953-24) / 3 mL in 1 VIAL, SINGLE-DOSE | 2018-01-01 | 0000-00-00 | No | No | Current |