NAROPIN
- Product NDC
- 0404-9924
- 11-digit product format
- 004049924
- Labeler code
- 0404
- Product ID
- 0404-9924_47641628-e7ea-4e6b-a214-4a834fcc56be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropivacaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; PERINEURAL
- Labeler
- Henry Schein, Inc.
- Application
- NDA020533
- Marketing category
- NDA
- Marketing start
- 2022-01-13
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NAROPIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROPIVACAINE HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V910P86109 |
| Rxcui | 1734475, 1734476 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9924-30 | NAROPIN | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 5 |
| 0404-9924-30 | NAROPIN | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9924 | NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240910_6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9924-30 | 00404992430 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9924-30) / 30 mL in 1 VIAL, SINGLE-DOSE | 2022-01-13 | 0000-00-00 | No | No | Current |