Prescription drug · ANDA
Ropivacaine Hydrochloride NDC 71288-738
Ropivacaine hydrochloride 10 mg/mL · Injection, Solution · Epidural · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-738-21 | 71288073821 | 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-738-21) / 20 mL in 1 VIAL, SINGLE-DOSE (71288-738-20)Marketed from Jul 30, 2024 |
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)
- Ropivacaine Hydrochloride
- Generic name (nonproprietary)
- ropivacaine hydrochloride
- Active ingredients
- Ropivacaine hydrochloride — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218713
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 71288-738_f5ce6fdb-2cd1-4ebf-a884-541b2976534fSPL ID f5ce6fdb-2cd1-4ebf-a884-541b2976534fSPL set ID d00bfdee-d3e9-4faf-b079-43ac1add51b3RxCUI 905189, 1734084, 1734090, 1734203, 1734207, 1734475, 1734483UNII 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
N471288073821followed by a unit qualifier and the quantityPackage 71288-0738-21. 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)
Ropivacaine Hydrochloride Injection 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 Ropivacaine Hydrochloride Injection is an amide local anesthetic indicated in adults 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 :…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218713
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 |
|---|---|---|---|---|
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 2 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Meitheal Pharmaceuticals Inc. | 71288-732 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Meitheal Pharmaceuticals Inc. | 71288-735 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 2 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Meitheal Pharmaceuticals Inc. | 71288-733 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Meitheal Pharmaceuticals Inc. | 71288-734 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 7.5 mg/mL | Injection, SolutionEpidural, Perineural | Meitheal Pharmaceuticals Inc. | 71288-736 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 10 mg/mL | Injection, SolutionEpidural | Meitheal Pharmaceuticals Inc. | 71288-737 |