Levalbuterol
- Product NDC
- 0093-4148
- 11-digit product format
- 000934148
- Labeler code
- 0093
- Product ID
- 0093-4148_c4bbe9ea-2824-4b67-8557-830bbb80ba5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levalbuterol
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA090297
- Marketing category
- ANDA
- Marketing start
- 2013-04-29
- Substance
- LEVALBUTEROL HYDROCHLORIDE
- Active strength
- 1.25 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 | 1.25 mg/3mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | WDQ1526QJM |
| Rxcui | 242754, 311286, 349590 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-4148-45 | Levalbuterol | 3 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 3 | 14 | |
| 0093-4148-45 | Levalbuterol | 5 in 1 POUCH | SOLUTION | 5 | 14 | |
| 0093-4148-56 | Levalbuterol | 6 in 1 CARTON | SOLUTION | 6 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-4148-04 | ML - Milliliter | 0093-4148 | a9c5841b-13c7-492b-a0b6-4bd10cb913fb | 1 | 2013-06-04 |
| 0093-4148-45 | ML - Milliliter | 0093-4148 | 178511ae-5748-451e-8e8d-5d67ab6a8381 | 1 | 2019-01-24 |
| 0093-4148-56 | ML - Milliliter | 0093-4148 | 3d814135-5d30-44f1-8238-6d8be263c804 | 1 | 2019-01-24 |
| 0093-4148-64 | ML - Milliliter | 0093-4148 | a2226a08-7e15-4064-bdbe-acfb76f1c925 | 1 | 2013-05-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LEVALBUTEROL HYDROCHLORIDE | ACTIVE INGREDIENT | WDQ1526QJM | LEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC] | 5 | |
| LEVALBUTEROL | ACTIVE MOIETY | EDN2NBH5SS | LEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC] | 5 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | LEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC] | 5 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | LEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC] | 5 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | LEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVALBUTEROL SOLUTION [TEVA PHARMACEUTICALS USA INC] | 5 |
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 | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d | 14 |
| 311286 | levalbuterol HCl 0.63 MG in 3 ML Inhalation Solution | PSN | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d | 14 |
| 242754 | levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution | PSN | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d | 14 |
| 349590 | levalbuterol 0.103 MG/ML Inhalation Solution | SCD | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d | 14 |
| 311286 | levalbuterol 0.21 MG/ML Inhalation Solution | SCD | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d | 14 |
| 242754 | levalbuterol 0.417 MG/ML Inhalation Solution | SCD | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d | 14 |
| 349590 | levalbuterol 0.31 MG (as levalbuterol HCl 0.36 MG) per 3 ML Inhalation Solution | SY | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d | 14 |
| 311286 | levalbuterol 0.63 MG (as levalbuterol HCl 0.73 MG) per 3 ML Inhalation Solution | SY | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d | 14 |
| 242754 | levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution | SY | f3ce78d9-e923-400e-b3cd-3e6124ac7f6d | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0093-4148-45 | 00093414845 | 3 mL in 1 VIAL, SINGLE-DOSE | 3 ml | Historical | ||||
| 0093-4148-56 | 00093414856 | 6 POUCH in 1 CARTON (0093-4148-56) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4148-45) / 3 mL in 1 VIAL, SINGLE-DOSE | 6 pouch | 2019-01-07 | 0000-00-00 | No | No | Current |