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
Product NDC (as listed)83854-013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83854-0013Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
83854-013-108385400131010 VIAL in 1 CARTON (83854-013-10) / 20 mL in 1 VIAL (83854-013-01)Marketed from Mar 21, 2025
83854-013-258385400132525 VIAL in 1 CARTON (83854-013-25) / 20 mL in 1 VIAL (83854-013-01)Marketed from Mar 21, 2025
83854-013-268385400132625 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
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

N483854001310 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 219883

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 219883
ProductStrengthForm · routeLabelerProduct NDC
Ropivacaine HydrochlorideRopivacaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralAnthea Pharma Private Limited83854-015
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralAnthea Pharma Private Limited83854-014
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, InfiltrationGlenmark Pharmaceuticals Inc., USA68462-777
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralGlenmark Pharmaceuticals Inc., USA68462-778
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralGlenmark Pharmaceuticals Inc., USA68462-794
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, InfiltrationGlenmark Pharmaceuticals Inc., USA68462-793
Ropivacaine HydrochlorideRopivacaine hydrochloride 10 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralGlenmark Pharmaceuticals Inc., USA68462-795

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Ropivacaine Hydrochloride NDC 83854-013 | Med-Code