ROPIVACAINE HYDROCHLORIDE
- Product NDC
- 67457-798
- 11-digit product format
- 674570798
- Labeler code
- 67457
- Product ID
- 67457-798_78b68980-9e8d-4f38-ba2a-a9d520451f5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; PERINEURAL
- Labeler
- Mylan Institutional LLC
- Application
- ANDA206091
- Marketing category
- ANDA
- Marketing start
- 2024-03-18
- Substance
- ROPIVACAINE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| V910P86109 | ROPIVACAINE HYDROCHLORIDE | 132112-35-7 | ROPIVACAINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67457-798-99 | 67457079899 | 10 POUCH in 1 CARTON (67457-798-99) / 1 BAG in 1 POUCH (67457-798-10) / 100 mL in 1 BAG | 10 pouch | 2024-03-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| ROPIVACAINE HYDROCHLORIDE | Mylan Institutional LLC | 2023-12-15 | HUMAN PRESCRIPTION DRUG LABEL | 1 |