Xopenex
- Product NDC
- 21695-153
- 11-digit product format
- 216950153
- Labeler code
- 21695
- Product ID
- 21695-153_35eb525b-72a5-4ef9-a36a-531e9e6b3560
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levalbuterol hydrochloride
- Dosage form
- SOLUTION
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Rebel Distributors Corp
- Application
- NDA020837
- Marketing category
- NDA
- Marketing start
- 1999-04-01
- 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
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 21695-153-24 | 2019-09-24 | C162847 | 48780-1 | 934fe258-48ed-48b1-e053-8cdaa90a720a | Xopenex ® (levalbuterol HCl) Inhalation Solution 0.31 mg*, 0.63 mg*, 1.25 mg* |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-153-24 | Xopenex | 12 in 1 POUCH | SOLUTION | 12 | 1 | |
| 21695-153-24 | Xopenex | 2 in 1 CARTON | SOLUTION | 2 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-153-24 | ML - Milliliter | 21695-153 | d13e3830-3502-4c74-b148-072f224e7fd2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| levalbuterol hydrochloride | ACTIVE INGREDIENT | WDQ1526QJM | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| levalbuterol | ACTIVE MOIETY | EDN2NBH5SS | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| nitrogen | INACTIVE INGREDIENT | N762921K75 | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium chloride | INACTIVE INGREDIENT | 451W47IQ8X | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sulfuric acid | INACTIVE INGREDIENT | O40UQP6WCF | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | XOPENEX (LEVALBUTEROL HYDROCHLORIDE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 242754 | levalbuterol HCl 1.25 MG in 3 ML Inhalation Solution | PSN | 35eb525b-72a5-4ef9-a36a-531e9e6b3560 | 1 |
| 833470 | Xopenex 1.25 MG in 3 ML Inhalation Solution | PSN | 35eb525b-72a5-4ef9-a36a-531e9e6b3560 | 1 |
| 833470 | levalbuterol 0.417 MG/ML Inhalation Solution [Xopenex] | SBD | 35eb525b-72a5-4ef9-a36a-531e9e6b3560 | 1 |
| 242754 | levalbuterol 0.417 MG/ML Inhalation Solution | SCD | 35eb525b-72a5-4ef9-a36a-531e9e6b3560 | 1 |
| 242754 | levalbuterol 1.25 MG (as levalbuterol HCl 1.44 MG) per 3 ML Inhalation Solution | SY | 35eb525b-72a5-4ef9-a36a-531e9e6b3560 | 1 |
| 833470 | Xopenex 0.417 MG/ML Inhalation Solution | SY | 35eb525b-72a5-4ef9-a36a-531e9e6b3560 | 1 |
| 833470 | Xopenex 1.25 MG (as levalbuterol hydrochloride 1.44 MG) per 3 ML Inhalation Solution | SY | 35eb525b-72a5-4ef9-a36a-531e9e6b3560 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-153-24 | 21695015324 | 12 in 1 POUCH | Historical |