Ropivacaine Hydrochloride
- Product NDC
- 0143-9197
- 11-digit product format
- 001439197
- Labeler code
- 0143
- Product ID
- 0143-9197_c4abd4d6-435c-4d2a-b670-717af36ceada
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; PERINEURAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA211907
- Marketing category
- ANDA
- Marketing start
- 2025-11-07
- 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 | 1734347, 1734355, 1734479 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9197-01 | Ropivacaine Hydrochloride | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 2 |
| 0143-9197-24 | Ropivacaine Hydrochloride | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 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 |
|---|
| 0143-9197-01 | 00143919701 | 100 mL in 1 BAG | 100 ml | | | | Historical |
| 0143-9197-24 | 00143919724 | 24 BAG in 1 CASE (0143-9197-24) / 100 mL in 1 BAG (0143-9197-01) | 24 bag | 2025-11-07 | No | No | Current |