Prescription drug · ANDA

Ropivacaine Hydrochloride NDC 65219-632

Ropivacaine hydrochloride 2 mg/mL · Injection, Solution · Epidural, Infiltration, Perineural · FRESENIUS KABI USA, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)65219-632Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65219-0632Add 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
65219-632-106521906321024 BAG in 1 CASE (65219-632-10) / 100 mL in 1 BAG (65219-632-02)Marketed from Feb 3, 2025
65219-632-206521906322024 BAG in 1 CASE (65219-632-20) / 200 mL in 1 BAG (65219-632-04)Marketed from Feb 3, 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, Perineural
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212808
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 65219-632_7203f32f-2e48-4924-b882-d4f3863ae952SPL ID 7203f32f-2e48-4924-b882-d4f3863ae952SPL set ID da4a7675-97bf-4d2a-9fdc-c1b4b2999126RxCUI 1734347, 1734355UNII V910P86109UPC 0365219632047, 0365219632023
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

N465219063210 followed by a unit qualifier and the quantity

Package 65219-0632-10. 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 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 : epidural …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212808

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

FDA NDC Directory listings under ANDA 212808
ProductStrengthForm · routeLabelerProduct NDC
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjectionEpidural, Infiltration, PerineuralCivica, Inc.72572-707
Ropivacaine HydrochlorideRopivacaine hydrochloride 150 mg/30mLInjectionEpidural, Infiltration, PerineuralArmas Pharmaceuticals Inc.72485-519
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjectionEpidural, Infiltration, PerineuralCaplin Steriles Limited65145-107
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjectionEpidural, Infiltration, PerineuralCaplin Steriles Limited65145-108
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjectionEpidural, Infiltration, PerineuralCaplin Steriles Limited65145-109
Ropivacaine HydrochlorideRopivacaine hydrochloride 10 mg/mLInjectionEpiduralCaplin Steriles Limited65145-110
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjectionEpidural, InfiltrationCaplin Steriles Limited65145-166
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjectionEpidural, InfiltrationCaplin Steriles Limited65145-165
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjectionEpidural, Infiltration, PerineuralBaxter Healthcare Corporation43066-015
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjectionEpidural, Infiltration, PerineuralBaxter Healthcare Corporation43066-019
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjectionEpidural, Infiltration, PerineuralBaxter Healthcare Corporation43066-023
Ropivacaine HydrochlorideRopivacaine hydrochloride 10 mg/mLInjectionEpidural, Infiltration, PerineuralBaxter Healthcare Corporation43066-027
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralSOLA Pharmaceuticals, LLC70512-797
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralSOLA Pharmaceuticals, LLC70512-798

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