Prescription drug · ANDA

Ropivacaine Hydrochloride NDC 70069-064

Ropivacaine hydrochloride 5 mg/mL · Injection · Epidural, Infiltration, Perineural · Somerset Therapeutics, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)70069-064Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70069-0064Add 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
70069-064-01700690064011 VIAL in 1 CARTON (70069-064-01) / 30 mL in 1 VIALMarketed from Jun 15, 2018
70069-064-107006900641010 VIAL in 1 CARTON (70069-064-10) / 30 mL in 1 VIALMarketed from Dec 20, 2021
70069-064-257006900642525 VIAL in 1 CARTON (70069-064-25) / 30 mL in 1 VIALMarketed from Dec 20, 2021

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 — 5 mg/mL
Dosage form
Injection
Route
Epidural, Infiltration, Perineural
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207636
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 70069-064_79b226f0-c08a-4f84-bf2b-ae5c60e01d67SPL ID 79b226f0-c08a-4f84-bf2b-ae5c60e01d67SPL set ID ffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe64RxCUI 905189, 1734084, 1734090, 1734203, 1734207, 1734475, 1734483UNII V910P86109UPC 0370069062104, 0370069062258, 0370069064252, 0370069061251, 0370069064016, 0370069063255, 0370069067017, 0370069066102, 0370069067109, 0370069063019, 0370069061015, 0370069065259, 0370069062012, 0370069064108, 0370069066256, 0370069067253, 0370069061107, 0370069066010, 0370069065013
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

N470069006401 followed by a unit qualifier and the quantity

Package 70069-0064-01. 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 Managemen t:…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207636

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

FDA NDC Directory listings under ANDA 207636
ProductStrengthForm · routeLabelerProduct NDC
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjectionEpidural, Infiltration, PerineuralSportpharm LLC85766-097
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjectionEpidural, Infiltration, PerineuralProPharma Distribution84549-164
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjectionEpidural, Infiltration, PerineuralSomerset Therapeutics, LLC70069-061
Ropivacaine HydrochlorideRopivacaine hydrochloride 7.5 mg/mLInjectionEpidural, PerineuralSomerset Therapeutics, LLC70069-065
Ropivacaine HydrochlorideRopivacaine hydrochloride 2 mg/mLInjectionEpidural, Infiltration, PerineuralSomerset Therapeutics, LLC70069-062
Ropivacaine HydrochlorideRopivacaine hydrochloride 5 mg/mLInjectionEpidural, Infiltration, PerineuralSomerset Therapeutics, LLC70069-063
Ropivacaine HydrochlorideRopivacaine hydrochloride 10 mg/mLInjectionEpiduralSomerset Therapeutics, LLC70069-066
Ropivacaine HydrochlorideRopivacaine hydrochloride 10 mg/mLInjectionEpiduralSomerset Therapeutics, LLC70069-067

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Ropivacaine Hydrochloride NDC 70069-064 | Med-Code