Esmolol Hydrochloride
- Product NDC
- 63323-652
- 11-digit product format
- 633230652
- Labeler code
- 63323
- Product ID
- 63323-652_961c04d5-1f12-4095-a4b9-1842574f7f97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESMOLOL HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA076573
- Marketing category
- ANDA
- Marketing start
- 2004-11-30
- 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 |
|---|
| 63323-652-01 | Esmolol Hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 6 |
| 63323-652-10 | Esmolol Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESMOLOL HYDROCHLORIDE | ACTIVE INGREDIENT | V05260LC8D | ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| ESMOLOL | ACTIVE MOIETY | MDY902UXSR | ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-652 | ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241127_fdc9cea8-0eb4-4930-9e1c-d44bfa9346d2.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 |
|---|
| 63323-652-01 | 63323065201 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 63323-652-10 | 63323065210 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-652-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-652-01) | | 2004-11-30 | 0000-00-00 | No | No | Current |