Esmolol Hydrochloride
- Product NDC
- 0404-9785
- 11-digit product format
- 004049785
- Labeler code
- 0404
- Product ID
- 0404-9785_20a0bd84-7968-459c-8218-2b2c98beb7d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esmolol hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA076474
- Marketing category
- ANDA
- Marketing start
- 2025-06-10
- Substance
- ESMOLOL HYDROCHLORIDE
- Active strength
- 10 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V05260LC8D |
| Rxcui | 1736546 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9785-10 | Esmolol Hydrochloride | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 2 |
| 0404-9785-10 | Esmolol Hydrochloride | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9785-10 | 00404978510 | 1 VIAL in 1 BAG (0404-9785-10) / 10 mL in 1 VIAL | 1 vial | 2025-06-10 | No | No | Historical |