Prescription drug · ANDA
Ropivacaine Hydrochloride NDC 84549-164
Ropivacaine hydrochloride 5 mg/mL · Injection · Epidural, Infiltration, Perineural · ProPharma Distribution
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84549-164-25 | 84549016425 | 30 mL in 1 VIAL (84549-164-25)Marketed from Oct 10, 2025 |
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 — 5 mg/mL
- Dosage form
- Injection
- Route
- Epidural, Infiltration, Perineural
- Labeler
- ProPharma Distribution
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207636
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 84549-164_463f04e3-2619-2343-e063-6394a90a6ae4SPL ID 463f04e3-2619-2343-e063-6394a90a6ae4SPL set ID 3f793f80-57da-1599-e063-6394a90a1dabRxCUI 1734475UNII 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
N484549016425followed by a unit qualifier and the quantityPackage 84549-0164-25. 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 Managemen t:…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207636
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 5 mg/mL | InjectionEpidural, Infiltration, Perineural | Sportpharm LLC | 85766-097 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 2 mg/mL | InjectionEpidural, Infiltration, Perineural | Somerset Therapeutics, LLC | 70069-061 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 7.5 mg/mL | InjectionEpidural, Perineural | Somerset Therapeutics, LLC | 70069-065 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 2 mg/mL | InjectionEpidural, Infiltration, Perineural | Somerset Therapeutics, LLC | 70069-062 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | InjectionEpidural, Infiltration, Perineural | Somerset Therapeutics, LLC | 70069-063 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | InjectionEpidural, Infiltration, Perineural | Somerset Therapeutics, LLC | 70069-064 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 10 mg/mL | InjectionEpidural | Somerset Therapeutics, LLC | 70069-066 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 10 mg/mL | InjectionEpidural | Somerset Therapeutics, LLC | 70069-067 |