Levalbuterol Hydrochloride
- Product NDC
- 76204-003
- 11-digit product format
- 762040003
- Labeler code
- 76204
- Product ID
- 76204-003_f54c79f2-308f-4c04-8a6f-186fbc90bb8c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levalbuterol Hydrochloride
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Ritedose Pharmaceuticals, LLC
- Application
- NDA020837
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-12-01
- Marketing end
- 0000-00-00
- Substance
- LEVALBUTEROL HYDROCHLORIDE
- Active strength
- 1 mg/3mL
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76204-003-24 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ebe7-f424-e053-dadaa90a57ce | 6925ab5e-4f50-4d04-b55a-8a6f74474382 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76204-003-24 | Levalbuterol Hydrochloride | 2 in 1 CARTON | SOLUTION | 2 | 1 | |
| 76204-003-24 | Levalbuterol Hydrochloride | 12 in 1 POUCH | SOLUTION | 12 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76204-003-24 | ML - Milliliter | 76204-003 | c4e40156-3750-456d-a2f2-62a9c9ee8b9e | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Levalbuterol Hydrochloride | ACTIVE INGREDIENT | WDQ1526QJM | LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] | 1 | |
| Levalbuterol | ACTIVE MOIETY | EDN2NBH5SS | LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] | 1 | |
| Sulfuric Acid | INACTIVE INGREDIENT | O40UQP6WCF | LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | LEVALBUTEROL HYDROCHLORIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311286 | levalbuterol HCl 0.63 MG in 3 ML Inhalation Solution | PSN | 6925ab5e-4f50-4d04-b55a-8a6f74474382 | 1 |
| 242754 | levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution | PSN | 6925ab5e-4f50-4d04-b55a-8a6f74474382 | 1 |
| 311286 | levalbuterol 0.21 MG/ML Inhalation Solution | SCD | 6925ab5e-4f50-4d04-b55a-8a6f74474382 | 1 |
| 242754 | levalbuterol 0.417 MG/ML Inhalation Solution | SCD | 6925ab5e-4f50-4d04-b55a-8a6f74474382 | 1 |
| 311286 | levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation Solution | SY | 6925ab5e-4f50-4d04-b55a-8a6f74474382 | 1 |
| 242754 | levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution | SY | 6925ab5e-4f50-4d04-b55a-8a6f74474382 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 76204-003-24 | 76204000324 | 2 in 1 CARTON | Historical |