Ropivacaine hydrochloride
- Product NDC
- 68083-263
- 11-digit product format
- 680830263
- Labeler code
- 68083
- Product ID
- 68083-263_59ffca85-dbbf-49c1-8516-027b9de5f396
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropivacaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION
- Labeler
- Gland Pharma Limited
- Application
- ANDA210102
- Marketing category
- ANDA
- Marketing start
- 2022-08-18
- Substance
- ROPIVACAINE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ropivacaine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROPIVACAINE HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V910P86109 |
| Rxcui | 1734347, 1734355 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-263-01 | Ropivacaine hydrochloride | 200 mL in 1 BAG | INJECTION, SOLUTION | 200 | | 6 |
| 68083-263-01 | Ropivacaine hydrochloride | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-263 | ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220824_643c1729-096e-459c-80c1-78b78e698da6.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 |
|---|
| 68083-263-01 | 68083026301 | 1 BAG in 1 POUCH (68083-263-01) / 200 mL in 1 BAG | 1 bag | 2022-08-18 | 0000-00-00 | No | No | Current |