Esmolol Hydrochloride
- Product NDC
- 84549-194
- 11-digit product format
- 845490194
- Labeler code
- 84549
- Product ID
- 84549-194_463cc756-d1d0-9ffe-e063-6394a90ab342
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esmolol Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA205520
- Marketing category
- ANDA
- Marketing start
- 2015-07-23
- Substance
- ESMOLOL HYDROCHLORIDE
- Active strength
- 100 mg/10mL
- 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 | 100 mg/10mL |
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 |
|---|
| 84549-194-10 | Esmolol Hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84549-194-10 | 84549019410 | 10 mL in 1 VIAL, SINGLE-DOSE (84549-194-10) | 10 ml | 2025-08-27 | No | No | Current |