Prescription drug · ANDA

Ropivacaine Hydrochloride NDC 55150-196

Ropivacaine hydrochloride 2 mg/mL · Injection, Solution · Epidural, Infiltration, Perineural · Eugia US LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55150-196Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55150-0196Add 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
55150-196-99551500196991 BOTTLE, GLASS in 1 CARTON (55150-196-99) / 100 mL in 1 BOTTLE, GLASSMarketed from Sep 15, 2016

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 205612
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 55150-196_1e5f1368-058a-492c-b4b7-d9329a7745e2SPL ID 1e5f1368-058a-492c-b4b7-d9329a7745e2SPL set ID 3763b7b6-da49-4658-b93d-28f5da24d09eRxCUI 905189, 1734084, 1734090, 1734207, 1734347, 1734475, 1734483UNII V910P86109UPC 0355150195206, 0355150199204, 0355150198306, 0355150196999, 0355150200108, 0355150197200, 0355150201204
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

N455150019699 followed by a unit qualifier and the quantity

Package 55150-0196-99. 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 Management :…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205612

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

FDA NDC Directory listings under ANDA 205612
ProductStrengthForm · routeLabelerProduct NDC
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralEugia US LLC55150-197
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralEugia US LLC55150-195
Ropivacaine HydrochlorideRopivacaine hydrochloride 10 mg/mLInjection, SolutionEpiduralEugia US LLC55150-201
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralEugia US LLC55150-198
Ropivacaine HydrochlorideRopivacaine hydrochloride 7.5 mg/mLInjection, SolutionEpidural, PerineuralEugia US LLC55150-199
Ropivacaine HydrochlorideRopivacaine hydrochloride 10 mg/mLInjection, SolutionEpiduralEugia US LLC55150-200
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralSportpharm LLC85766-098

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Ropivacaine Hydrochloride NDC 55150-196 | Med-Code