Isoproterenol Hydrochloride
- Product NDC
- 83634-303
- 11-digit product format
- 836340303
- Labeler code
- 83634
- Product ID
- 83634-303_ded94bcc-5654-4017-b3e6-65f1226beca1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isoproterenol hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avenacy, Inc.
- Application
- ANDA212189
- Marketing category
- ANDA
- Marketing start
- 2024-05-15
- Substance
- ISOPROTERENOL HYDROCHLORIDE
- Active strength
- .2 mg/mL
- Pharmacologic classes
- Adrenergic beta-Agonists [MoA], beta-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
- Isoproterenol Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOPROTERENOL HYDROCHLORIDE | .2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DIA2A74855 |
| Rxcui | 1667909, 1667915 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83634-303-01 | Isoproterenol Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
| 83634-303-05 | Isoproterenol Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
| 83634-303-41 | Isoproterenol Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 1 |
| 83634-303-42 | Isoproterenol Hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-303 | ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [AVENACY, INC.] | 1 | Current NDC, 4 package rows | 20240515_212af0f4-42c7-425d-8baf-9a2f594289a2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83634-303-01 | 83634030301 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-303-01) / 1 mL in 1 VIAL, SINGLE-DOSE (83634-303-41) | | 2024-05-15 | No | No | Current |
| 83634-303-05 | 83634030305 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-303-05) / 5 mL in 1 VIAL, SINGLE-DOSE (83634-303-42) | | 2024-05-15 | No | No | Current |
| 83634-303-41 | 83634030341 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 83634-303-42 | 83634030342 | 5 mL in 1 VIAL, SINGLE-DOSE | 5 ml | | | | Historical |