ISOPROTERENOL HYDROCHLORIDE
- Product NDC
- 0548-9501
- 11-digit product format
- 005489501
- Labeler code
- 0548
- Product ID
- 0548-9501_03384075-bc26-4df6-b1e3-0e20e8808d65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isoproterenol Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Amphastar Pharmaceuticals, Inc.
- Application
- ANDA210106
- Marketing category
- ANDA
- Marketing start
- 2018-07-16
- 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 |
|---|
| 0548-9501-00 | ISOPROTERENOL HYDROCHLORIDE | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 2 |
| 0548-9501-00 | ISOPROTERENOL HYDROCHLORIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0548-9501 | ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [AMPHASTAR PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20181012_86b2455a-0489-405e-bd0b-9f79d3c5350d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0548-9501-00 | 00548950100 | 10 VIAL in 1 CARTON (0548-9501-00) / 1 mL in 1 VIAL | 10 vial | 2018-07-16 | 0000-00-00 | No | No | Current |