Ropivacaine Hydrochloride
- Product NDC
- 17478-081
- 11-digit product format
- 174780081
- Labeler code
- 17478
- Product ID
- 17478-081_33a30541-92c1-4971-9d49-da4425274d25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; PERINEURAL
- Labeler
- Akorn
- Application
- ANDA203955
- Marketing category
- ANDA
- Marketing start
- 2016-04-11
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17478-081-30 | Ropivacaine Hydrochloride | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 7 |
| 17478-081-30 | Ropivacaine Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-081 | ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AKORN] | 7 | Legacy NDC, 2 package rows | 20220916_187fccbf-329a-4af1-a16e-f13c0e2bd73d.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 |
|---|
| 17478-081-30 | 17478008130 | 1 VIAL, SINGLE-DOSE in 1 CARTON (17478-081-30) > 30 mL in 1 VIAL, SINGLE-DOSE | 2016-04-11 | 0000-00-00 | No | No | Current |