Ropivacaine Hydrochloride
- Product NDC
- 67457-878
- 11-digit product format
- 674570878
- Labeler code
- 67457
- Product ID
- 67457-878_7006cce5-a917-4f4d-9620-1933ef256a87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropivacaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; PERINEURAL
- Labeler
- Mylan Institutional LLC
- Application
- ANDA090318
- Marketing category
- ANDA
- Marketing start
- 2019-05-23
- Marketing end
- 2021-03-31
- Substance
- ROPIVACAINE HYDROCHLORIDE
- Active strength
- 150 mg/20mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 67457-878 | | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A090318-001 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |
| A090318-002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |
| A090318-003 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |
| A090318-004 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |