Ropivacaine Hydrochloride
- Product NDC
- 85766-097
- 11-digit product format
- 857660097
- Labeler code
- 85766
- Product ID
- 85766-097_5031af45-1202-6839-e063-6294a90a15f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropivacaine Hydrochloride
- Dosage form
- INJECTION
- Route
- EPIDURAL; INFILTRATION; PERINEURAL
- Labeler
- Sportpharm LLC
- Application
- ANDA207636
- Marketing category
- ANDA
- Marketing start
- 2018-06-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ropivacaine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROPIVACAINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V910P86109 |
| Rxcui | 1734475 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-097-30 | Ropivacaine Hydrochloride | 30 mL in 1 VIAL | INJECTION | 30 | | 2 |
| 85766-097-30 | Ropivacaine Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-097-30 | 85766009730 | 1 VIAL in 1 CARTON (85766-097-30) / 30 mL in 1 VIAL | 1 vial | 2025-10-08 | No | No | Historical |