ESMOLOL HYDROCHLORIDE
- Product NDC
- 51662-1444
- 11-digit product format
- 516621444
- Labeler code
- 51662
- Product ID
- 51662-1444_101e0203-54eb-a48a-e063-6294a90af0d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESMOLOL HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA205520
- Marketing category
- ANDA
- Marketing start
- 2019-12-22
- 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 |
|---|
| 51662-1444-1 | ESMOLOL HYDROCHLORIDE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 4 |
| 51662-1444-2 | ESMOLOL HYDROCHLORIDE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 4 |
| 51662-1444-2 | ESMOLOL HYDROCHLORIDE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
| 51662-1444-3 | ESMOLOL HYDROCHLORIDE | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1444 | ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240131_9a52d2fd-e551-f8f1-e053-2995a90a6c09.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 |
|---|
| 51662-1444-1 | 51662144401 | 10 mL in 1 VIAL, SINGLE-DOSE (51662-1444-1) | 10 ml | 2019-12-22 | 0000-00-00 | No | No | Current |
| 51662-1444-2 | 51662144402 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 51662-1444-3 | 51662144403 | 25 POUCH in 1 CASE (51662-1444-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1444-2) / 10 mL in 1 VIAL, SINGLE-DOSE | 25 pouch | 2022-09-12 | 0000-00-00 | No | No | Current |