ROPIVACAINE HYDROCHLORIDE
- Product NDC
- 68462-795
- 11-digit product format
- 684620795
- Labeler code
- 68462
- Product ID
- 68462-795_94b5c770-9085-490d-a39c-5c9f8c659118
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; PERINEURAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA219883
- Marketing category
- ANDA
- Marketing start
- 2025-08-07
- Substance
- ROPIVACAINE HYDROCHLORIDE
- Active strength
- 10 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 |
|---|---|
| ROPIVACAINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | V910P86109 |
| Rxcui | 1734084, 1734203, 1734207, 1734475, 1734483 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68462-795-20 | ROPIVACAINE HYDROCHLORIDE | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | 3 | |
| 68462-795-55 | ROPIVACAINE HYDROCHLORIDE | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-795-20 | ML - Milliliter | 68462-795 | cace828f-14e7-4550-bcf3-f47006788eb4 | 1 | 2025-12-16 |
| 68462-795-55 | ML - Milliliter | 68462-795 | e2b54245-c4c3-4d82-ba4f-7085ee721b74 | 1 | 2025-12-16 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1734203 | ROPivacaine HCl 0.2 % in 10 ML Injection | PSN | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734207 | ROPivacaine HCl 0.2 % in 20 ML Injection | PSN | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734483 | ROPivacaine HCl 0.5 % in 20 ML Injection | PSN | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734475 | ROPivacaine HCl 0.5 % in 30 ML Injection | PSN | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734084 | ROPivacaine HCl 1 % in 20 ML Injection | PSN | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734203 | 10 ML ropivacaine hydrochloride 2 MG/ML Injection | SCD | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734084 | 20 ML ropivacaine hydrochloride 10 MG/ML Injection | SCD | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734207 | 20 ML ropivacaine hydrochloride 2 MG/ML Injection | SCD | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734483 | 20 ML ropivacaine hydrochloride 5 MG/ML Injection | SCD | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734475 | 30 ML ropivacaine hydrochloride 5 MG/ML Injection | SCD | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734203 | ropivacaine HCl 0.2 % per 10 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734207 | ropivacaine HCl 0.2 % per 20 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734483 | ropivacaine HCl 0.5 % per 20 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734475 | ropivacaine HCl 0.5 % per 30 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734084 | ropivacaine HCl 1 % per 20 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734483 | ropivacaine HCl 100 MG per 20 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734475 | ropivacaine HCl 150 MG per 30 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734203 | ropivacaine HCl 20 MG per 10 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734084 | ropivacaine HCl 200 MG per 20 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
| 1734207 | ropivacaine HCl 40 MG per 20 ML Injection | SY | 043b28cc-ce5c-4351-a646-704c381decb9 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68462-795-20 | 68462079520 | 20 mL in 1 VIAL | 20 ml | Historical | |||
| 68462-795-55 | 68462079555 | 25 VIAL in 1 CARTON (68462-795-55) / 20 mL in 1 VIAL (68462-795-20) | 25 vial | 2025-08-07 | No | No | Current |