Esmolol Hydrochloride
- Product NDC
- 68083-211
- 11-digit product format
- 680830211
- Labeler code
- 68083
- Product ID
- 68083-211_91f3287c-e1f4-48a0-a37e-74da91240a2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esmolol Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA208538
- Marketing category
- ANDA
- Marketing start
- 2019-08-19
- 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 |
|---|
| 68083-211-01 | Esmolol Hydrochloride | 10 mL in 1 VIAL | INJECTION | 10 | | 5 |
| 68083-211-25 | Esmolol Hydrochloride | 25 in 1 CARTON | INJECTION | 25 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-211 | ESMOLOL HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230713_017023a9-00f0-4284-861f-a3634d4fdb17.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 |
|---|
| 68083-211-01 | 68083021101 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 68083-211-25 | 68083021125 | 25 VIAL in 1 CARTON (68083-211-25) / 10 mL in 1 VIAL (68083-211-01) | 25 vial | 2019-08-19 | 0000-00-00 | No | No | Current |