esmolol hydrochloride in sodium chloride
- Product NDC
- 67457-657
- 11-digit product format
- 674570657
- Labeler code
- 67457
- Product ID
- 67457-657_f5590283-06f2-43c7-9e1b-2a762f568bbf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esmolol hydrochloride in sodium chloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA206608
- Marketing category
- ANDA
- Marketing start
- 2018-09-04
- 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 in sodium chloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESMOLOL HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V05260LC8D |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-657-25 | esmolol hydrochloride in sodium chloride | 250 mL in 1 BAG | INJECTION | 250 | | 3 |
| 67457-657-25 | esmolol hydrochloride in sodium chloride | 1 in 1 POUCH | INJECTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-657 | ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE INJECTION [MYLAN INSTITUTIONAL LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20180904_01ad7942-99c3-40ee-9cfb-272fb6c44e2b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-657-25 | 67457065725 | 1 BAG in 1 POUCH (67457-657-25) / 250 mL in 1 BAG | 1 bag | 2018-09-04 | 0000-00-00 | No | No | Current |