ESMOLOL HYDROCHLORIDE
- Product NDC
- 52584-194
- 11-digit product format
- 525840194
- Labeler code
- 52584
- Product ID
- 52584-194_facd8da8-e695-42d7-916b-04706eaa3195
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESMOLOL HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- General Injectables and Vaccines, Inc.
- Application
- ANDA205520
- Marketing category
- ANDA
- Marketing start
- 2018-09-20
- Marketing end
- 2023-12-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-194-10 | 52584019410 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-194-10) > 10 mL in 1 VIAL, SINGLE-DOSE | 2018-09-20 | 0000-00-00 | No | No | Current |