ropivacaine hydrochloride
- Product NDC
- 25021-652
- 11-digit product format
- 250210652
- Labeler code
- 25021
- Product ID
- 25021-652_41f4446a-ca6e-465e-9a79-8c4f99eb1ac3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropivacaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA206166
- Marketing category
- ANDA
- Marketing start
- 2019-07-15
- 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 | 1734347, 1734355, 1734479, 1734481 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-652-82 | ropivacaine hydrochloride | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 11 |
| 25021-652-82 | ropivacaine hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 11 |
| 25021-652-87 | ropivacaine hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 11 |
| 25021-652-87 | ropivacaine hydrochloride | 200 mL in 1 BAG | INJECTION, SOLUTION | 200 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-652 | ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 10 | Current NDC, Legacy NDC, 4 package rows | 20240328_8c5c762f-d266-4b1a-809e-f11bfc89bc2d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 25021-652-82 | 25021065282 | 10 BAG in 1 CARTON (25021-652-82) / 100 mL in 1 BAG | 10 bag | 2019-07-15 | 0000-00-00 | No | No | Current |
| 25021-652-87 | 25021065287 | 10 BAG in 1 CARTON (25021-652-87) / 200 mL in 1 BAG | 10 bag | 2019-07-15 | 0000-00-00 | No | No | Current |