Ropivacaine Hydrochloride
- Product NDC
- 0781-3140
- 11-digit product format
- 007813140
- Labeler code
- 0781
- Product ID
- 0781-3140_b48c183c-69f9-411c-a27b-9e31b3876ede
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- PARENTERAL
- Labeler
- Sandoz Inc
- Application
- ANDA078601
- Marketing category
- ANDA
- Marketing start
- 2014-07-24
- Marketing end
- 0000-00-00
- Substance
- ROPIVACAINE HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 | 0781-3140 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0781-3140 | 0781-3140-14 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0781-3140 | 0781-3140-30 | 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 |
|---|
| A078601-002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | AP | | 2014-07-17 |
| A078601-003 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | AP | | 2014-07-17 |
Therapeutic equivalence codes#
FDA-Initiated Inactive NDC Indexing#