esmolol hydrochloride
- Product NDC
- 55150-421
- 11-digit product format
- 551500421
- Labeler code
- 55150
- Product ID
- 55150-421_5aebd586-47c6-4e19-88e3-ef0ecb1cc875
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esmolol hydrochloride in sodium chloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA216244
- Marketing category
- ANDA
- Marketing start
- 2022-03-21
- Substance
- ESMOLOL HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- esmolol hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESMOLOL HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V05260LC8D |
| Rxcui | 979432, 1736541, 1736546 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-421-01 | esmolol hydrochloride | 1 in 1 POUCH | INJECTION | 1 | | 6 |
| 55150-421-01 | esmolol hydrochloride | 100 mL in 1 BAG | INJECTION | 100 | | 6 |
| 55150-421-10 | esmolol hydrochloride | 10 in 1 CARTON | INJECTION | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-421 | ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION ESMOLOL HYDROCHLORIDE (ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [EUGIA US LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240919_ac22475d-2d78-469f-9435-b403ac4ee380.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 |
|---|
| 55150-421-01 | 55150042101 | 1 in 1 POUCH | | | | | | Historical |
| 55150-421-10 | 55150042110 | 10 POUCH in 1 CARTON (55150-421-10) / 1 BAG in 1 POUCH (55150-421-01) / 100 mL in 1 BAG | 10 pouch | 2022-03-21 | 0000-00-00 | No | No | Current |