Prescription drug · NDA
Naropin (Ropivacaine hydrochloride) NDC 63323-285
Ropivacaine hydrochloride 2 mg/mL · Injection, Solution · Epidural, Infiltration · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-285-67 | 6332302856763323028567 | 12 BOTTLE in 1 CASE (63323-285-67) / 100 mL in 1 BOTTLE (63323-285-55)Marketed from Aug 4, 2009 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Naropin
- Generic name (nonproprietary)
- ropivacaine hydrochloride
- Active ingredients
- Ropivacaine hydrochloride — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020533
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 63323-285_73218c89-8925-468c-84bf-9960b4b3dc3cSPL ID 73218c89-8925-468c-84bf-9960b4b3dc3cSPL set ID c6613708-c1f7-4f5c-91a3-ebbc1d7905c6RxCUI 1734084, 1734086, 1734090, 1734091, 1734203, 1734204, 1734207, 1734208, 1734347, 1734348, 1734355, 1734356, 1734475, 1734476, 1734479, 1734480, 1734481, 1734482, 1734483, 1734484UNII V910P86109UPC 0363323285555, 0363323286934, 0363323288235
- Pharmacologic class
- Amide Local Anesthetic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N463323028567followed by a unit qualifier and the quantityPackage 63323-0285-67. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
NAROPIN is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration NAROPIN is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesi a: epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g…
Excerpt only. Read the full label for complete information.
About NDC 63323-285
- What is NDC 63323-285?
- 63323-285 is the product NDC for Naropin (ropivacaine hydrochloride), Ropivacaine hydrochloride 2 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naropin (Ropivacaine hydrochloride).
- What is the active ingredient?
- Ropivacaine hydrochloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naropin?
- 4 other product NDCs are listed under this name. See all Naropin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naropin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naropinropivacaine hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Henry Schein, Inc. | 0404-9924 | 00404-9924-30 |
| Naropinropivacaine hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Fresenius Kabi USA, LLC | 63323-286 | 63323-0286-0063323-0286-2063323-0286-23+4 more |
| Naropinropivacaine hydrochloride | Ropivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Perineural | Fresenius Kabi USA, LLC | 63323-287 | 63323-0287-2063323-0287-21 |
| Naropinropivacaine hydrochloride | Ropivacaine hydrochloride 10 mg/mL | Injection, SolutionEpidural | Fresenius Kabi USA, LLC | 63323-288 | 63323-0288-27 |
Other NDCs under NDA 020533
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Naropinropivacaine hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Henry Schein, Inc. | 0404-9924 |
| Naropinropivacaine hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Fresenius Kabi USA, LLC | 63323-286 |
| Naropinropivacaine hydrochloride | Ropivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Perineural | Fresenius Kabi USA, LLC | 63323-287 |
| Naropinropivacaine hydrochloride | Ropivacaine hydrochloride 10 mg/mL | Injection, SolutionEpidural | Fresenius Kabi USA, LLC | 63323-288 |