Prescription drug · ANDA

Ropivacaine Hydrochloride NDC 43066-027

Ropivacaine hydrochloride 10 mg/mL · Injection · Epidural, Infiltration, Perineural · Baxter Healthcare Corporation

NDC codes

FDA NDC Directory
Product NDC (as listed)43066-027Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43066-0027Add 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
43066-027-104306600271010 VIAL in 1 CARTON (43066-027-10) / 20 mL in 1 VIAL (43066-027-01)Marketed from Apr 9, 2020

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
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 43066-027_a8d08579-825f-40d9-b1e3-e47b73765ae6SPL ID a8d08579-825f-40d9-b1e3-e47b73765ae6SPL set ID 781d4b7f-7556-4695-8d48-7772d7a0d8e9RxCUI 1734084, 1734207, 1734475, 1734483UNII V910P86109UPC 0343066023010, 0343066019013, 0343066027018, 0343066015015
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

N443066002710 followed by a unit qualifier and the quantity

Package 43066-0027-10. 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 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 continuous …

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 2 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralSOLA Pharmaceuticals, LLC70512-797
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralFRESENIUS KABI USA, LLC65219-632
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralSOLA Pharmaceuticals, LLC70512-798

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Ropivacaine Hydrochloride NDC 43066-027 | Med-Code