Prescription drug · ANDA
Ropivacaine Hydrochloride NDC 83854-013
Ropivacaine hydrochloride 2 mg/mL · Injection, Solution · Epidural, Infiltration · Anthea Pharma Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83854-013-10 | 8385400131083854001310 | 10 VIAL in 1 CARTON (83854-013-10) / 20 mL in 1 VIAL (83854-013-01)Marketed from Mar 21, 2025 | |
| 83854-013-25 | 8385400132583854001325 | 25 VIAL in 1 CARTON (83854-013-25) / 20 mL in 1 VIAL (83854-013-01)Marketed from Mar 21, 2025 | |
| 83854-013-26 | 8385400132683854001326 | 25 VIAL in 1 CARTON (83854-013-26) / 10 mL in 1 VIAL (83854-013-02)Marketed from Oct 8, 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 — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration
- Labeler
- Anthea Pharma Private LimitedNDC labeler code 83854
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219883
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 83854-013_428b4218-2c8d-6dee-e063-6394a90a1b89SPL ID 428b4218-2c8d-6dee-e063-6394a90a1b89SPL set ID f2b54355-a596-4f97-aeaa-d93e3984c42dRxCUI 1734084, 1734207, 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
N483854001310followed by a unit qualifier and the quantityPackage 83854-0013-10. 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 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. ( 1 ) Acute Pain Managemen…
Excerpt only. Read the full label for complete information.
About NDC 83854-013
- What is NDC 83854-013?
- 83854-013 is the product NDC for Ropivacaine Hydrochloride, Ropivacaine hydrochloride 2 mg/mL injection, solution, listed with the FDA by Anthea Pharma Private Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ropivacaine Hydrochloride.
- What is the active ingredient?
- Ropivacaine hydrochloride.
- Who is the labeler?
- Anthea Pharma Private Limited, NDC labeler code 83854. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ropivacaine Hydrochloride?
- 65 other product NDCs are listed under this name. See all Ropivacaine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ropivacaine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 150 mg/30mL | InjectionEpidural, Infiltration, Perineural | Armas Pharmaceuticals Inc. | 72485-519 | 72485-0519-10 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 2 mg/mL | InjectionEpidural, Infiltration | Hikma Pharmaceuticals USA Inc. | 0143-9263 | 00143-9263-10 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | InjectionEpidural, Infiltration | Hikma Pharmaceuticals USA Inc. | 0143-9264 | 00143-9264-10 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 7.5 mg/mL | InjectionEpidural | Hikma Pharmaceuticals USA Inc. | 0143-9265 | 00143-9265-10 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 10 mg/mL | InjectionEpidural | Hikma Pharmaceuticals USA Inc. | 0143-9266 | 00143-9266-10 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 2 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Hikma Pharmaceuticals USA Inc. | 0143-9195 | 00143-9195-24 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 2 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Hikma Pharmaceuticals USA Inc. | 0143-9196 | 00143-9196-12 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Hikma Pharmaceuticals USA Inc. | 0143-9197 | 00143-9197-24 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 2 mg/mL | Injection, SolutionEpidural, Infiltration | Glenmark Pharmaceuticals Inc., USA | 68462-777 | 68462-0777-35 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Glenmark Pharmaceuticals Inc., USA | 68462-778 | 68462-0778-5568462-0778-74 |
Other NDCs under ANDA 219883
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 | Glenmark Pharmaceuticals Inc., USA | 68462-777 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Glenmark Pharmaceuticals Inc., USA | 68462-778 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 2 mg/mL | Injection, SolutionEpidural, Infiltration | Glenmark Pharmaceuticals Inc., USA | 68462-793 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Glenmark Pharmaceuticals Inc., USA | 68462-794 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Glenmark Pharmaceuticals Inc., USA | 68462-795 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 5 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Anthea Pharma Private Limited | 83854-014 |
| Ropivacaine Hydrochloride | Ropivacaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration, Perineural | Anthea Pharma Private Limited | 83854-015 |