Prescription drug · NDA
Naropin (Ropivacaine hydrochloride) NDC 0404-9924
Ropivacaine hydrochloride 5 mg/mL · Injection, Solution · Epidural, Infiltration, Perineural · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9924-30 | 0040499243000404992430 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9924-30) / 30 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 13, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration, Perineural
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- 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 0404-9924_fbc94af4-148e-4507-8f09-37e72eada92cSPL ID fbc94af4-148e-4507-8f09-37e72eada92cSPL set ID 6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02RxCUI 1734475, 1734476UNII V910P86109
- 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
N400404992430followed by a unit qualifier and the quantityPackage 00404-9924-30. 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. (1) Surgical Anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus,…
Excerpt only. Read the full label for complete information.
About NDC 0404-9924
- What is NDC 0404-9924?
- 0404-9924 is the product NDC for Naropin (ropivacaine hydrochloride), Ropivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. 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?
- Henry Schein, Inc., NDC labeler code 0404. 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 2 mg/mL | Injection, SolutionEpidural, Infiltration | Fresenius Kabi USA, LLC | 63323-285 | 63323-0285-67 |
| 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 2 mg/mL | Injection, SolutionEpidural, Infiltration | Fresenius Kabi USA, LLC | 63323-285 |
| 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 |