Levalbuterol
- Product NDC
- 76204-800
- 11-digit product format
- 762040800
- Labeler code
- 76204
- Product ID
- 76204-800_459fa0f5-35d9-d6e5-e063-6394a90a6f14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levalbuterol Hydrochloride
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Ritedose Pharmaceuticals, LLC
- Application
- ANDA203653
- Marketing category
- ANDA
- Marketing start
- 2016-03-22
- 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 |
|---|---|
| LEVALBUTEROL HYDROCHLORIDE | .63 mg/3mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | WDQ1526QJM |
| Rxcui | 242754, 311286, 349590 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 3b93cc5d-8105-47d8-8ae6-077d0f655880 | Product name | 3 | 20190213 |
| 415a13b7-458d-4b44-ab20-f56d8ef7ab9d | Product name | 2 | 20170426 |
| a511b237-73ca-80ef-2a42-a935d09028ad | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76204-800-01 | Levalbuterol | 30 in 1 CARTON | SOLUTION | 30 | 22 | |
| 76204-800-05 | Levalbuterol | 5 in 1 POUCH | SOLUTION | 5 | 22 | |
| 76204-800-05 | Levalbuterol | 3 mL in 1 AMPULE | SOLUTION | 3 | 22 | |
| 76204-800-11 | Levalbuterol | 1 in 1 POUCH | SOLUTION | 1 | 22 | |
| 76204-800-11 | Levalbuterol | 3 mL in 1 AMPULE | SOLUTION | 3 | 22 | |
| 76204-800-15 | Levalbuterol | 3 mL in 1 AMPULE | SOLUTION | 3 | 22 | |
| 76204-800-15 | Levalbuterol | 25 in 1 POUCH | SOLUTION | 25 | 22 | |
| 76204-800-25 | Levalbuterol | 1 in 1 CARTON | SOLUTION | 1 | 22 | |
| 76204-800-55 | Levalbuterol | 5 in 1 CARTON | SOLUTION | 5 | 22 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76204-800-01 | ML - Milliliter | 76204-800 | e0725bdf-61e5-4b1d-a17a-52f53350b531 | 1 | 2017-07-07 |
| 76204-800-11 | ML - Milliliter | 76204-800 | e3158432-5144-4025-8892-4896b863c682 | 1 | 2017-07-07 |
| 76204-800-12 | ML - Milliliter | 76204-800 | b3ea1140-ada1-435f-90ba-1bda1fbccf7c | 1 | 2016-05-16 |
| 76204-800-15 | ML - Milliliter | 76204-800 | c8236cc1-42fa-44c6-95db-33d3811eac35 | 1 | 2017-08-11 |
| 76204-800-24 | ML - Milliliter | 76204-800 | 078d1508-6ce2-455e-9c40-21bc9b281ff9 | 1 | 2016-05-16 |
| 76204-800-25 | ML - Milliliter | 76204-800 | 17863b76-8f05-4dcd-a1f9-eba183a36506 | 1 | 2017-08-11 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349590 | levalbuterol HCl 0.31 MG in 3 ML Inhalation Solution | PSN | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 22 |
| 311286 | levalbuterol HCl 0.63 MG in 3 ML Inhalation Solution | PSN | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 22 |
| 242754 | levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution | PSN | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 22 |
| 349590 | levalbuterol 0.103 MG/ML Inhalation Solution | SCD | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 22 |
| 311286 | levalbuterol 0.21 MG/ML Inhalation Solution | SCD | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 22 |
| 242754 | levalbuterol 0.417 MG/ML Inhalation Solution | SCD | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 22 |
| 349590 | levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation Solution | SY | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 22 |
| 311286 | levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation Solution | SY | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 22 |
| 242754 | levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution | SY | d6998949-e1cb-4c86-a480-c0dfd9cb75b5 | 22 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76204-800-01 | 76204080001 | 30 POUCH in 1 CARTON (76204-800-01) / 1 AMPULE in 1 POUCH (76204-800-11) / 3 mL in 1 AMPULE | 30 pouch | 2017-02-17 | 0000-00-00 | No | No | Current |
| 76204-800-05 | 76204080005 | 5 in 1 POUCH | Historical | |||||
| 76204-800-11 | 76204080011 | 1 in 1 POUCH | Historical | |||||
| 76204-800-15 | 76204080015 | 3 mL in 1 AMPULE | 3 ml | Historical | ||||
| 76204-800-25 | 76204080025 | 1 POUCH in 1 CARTON (76204-800-25) / 25 AMPULE in 1 POUCH (76204-800-15) / 3 mL in 1 AMPULE | 1 pouch | 2017-02-17 | 0000-00-00 | No | No | Current |
| 76204-800-55 | 76204080055 | 5 POUCH in 1 CARTON (76204-800-55) / 5 AMPULE in 1 POUCH (76204-800-05) / 3 mL in 1 AMPULE | 5 pouch | 2017-02-17 | 0000-00-00 | No | No | Current |