NAROPIN
- Product NDC
- 52584-286
- 11-digit product format
- 525840286
- Labeler code
- 52584
- Product ID
- 52584-286_964e7997-ac3a-42a8-98d8-4a9f96979153
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropivacaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; INFILTRATION; PERINEURAL
- Labeler
- General Injectables & Vaccines, Inc
- Application
- NDA020533
- Marketing category
- NDA
- Marketing start
- 2014-03-11
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROPIVACAINE HYDROCHLORIDE | ACTIVE INGREDIENT | V910P86109 | NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 1 | |
| ROPIVACAINE | ACTIVE MOIETY | 7IO5LYA57N | NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52584-286 | NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 9 | Legacy NDC | 20230125_096c2693-8488-48c2-88ee-bf3df95c3f4c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-286-35 | 52584028635 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-286-35) > 30 mL in 1 VIAL, SINGLE-DOSE | 2014-03-11 | 0000-00-00 | No | No | Current |