Prescription drug · NDA

Naropin (ropivacaine hydrochloride) NDC 0404-9924

Ropivacaine hydrochloride 5 mg/mL · Injection, Solution · Epidural, Infiltration, Perineural · Henry Schein, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)0404-9924Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00404-9924Add 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
0404-9924-30004049924301 VIAL, SINGLE-DOSE in 1 BAG (0404-9924-30) / 30 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 13, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Naropin
Generic name (nonproprietary)
ropivacaine hydrochloride
Active ingredients
Ropivacaine hydrochloride — 5 mg/mL
Dosage form
Injection, Solution
Route
Epidural, Infiltration, Perineural
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020533
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 0404-9924_fbc94af4-148e-4507-8f09-37e72eada92cSPL ID fbc94af4-148e-4507-8f09-37e72eada92cSPL set ID 6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02RxCUI 1734475, 1734476UNII 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

N400404992430 followed by a unit qualifier and the quantity

Package 00404-9924-30. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 020533

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

FDA NDC Directory listings under NDA 020533
ProductStrengthForm · routeLabelerProduct NDC
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, InfiltrationFresenius Kabi USA, LLC63323-285
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, InfiltrationFresenius Kabi USA, LLC63323-285
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralFresenius Kabi USA, LLC63323-286
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 2 mg/mLInjection, SolutionEpidural, InfiltrationFresenius Kabi USA, LLC63323-285
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralFresenius Kabi USA, LLC63323-286
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 10 mg/mLInjection, SolutionEpiduralFresenius Kabi USA, LLC63323-288
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralFresenius Kabi USA, LLC63323-286
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Infiltration, PerineuralFresenius Kabi USA, LLC63323-286
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 7.5 mg/mLInjection, SolutionEpidural, PerineuralFresenius Kabi USA, LLC63323-287
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 10 mg/mLInjection, SolutionEpiduralFresenius Kabi USA, LLC63323-288
Naropinropivacaine hydrochlorideRopivacaine hydrochloride 10 mg/mLInjection, SolutionEpiduralFresenius Kabi USA, LLC63323-288

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in