Ropivacaine hydrochloride NDC 68083-262

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-262Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0262Add 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 NDC	11-digit (billing)	Package	Copy
68083-262-01	68083026201	1 BAG in 1 POUCH (68083-262-01) / 100 mL in 1 BAGMarketed from Aug 18, 2022

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
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210102
Marketing start: Aug 18, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 68083-262_59ffca85-dbbf-49c1-8516-027b9de5f396SPL ID 59ffca85-dbbf-49c1-8516-027b9de5f396SPL set ID 643c1729-096e-459c-80c1-78b78e698da6RxCUI 1734347, 1734355UNII V910P86109UPC 0368083262013, 0368083263010
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

N468083026201 followed by a unit qualifier and the quantity

Package 68083-0262-01. 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 Aug 22, 2022.

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: epi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210102

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

FDA NDC Directory listings under ANDA 210102
Product	Strength	Form · route	Labeler	Product NDC
Ropivacaine hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration	Gland Pharma Limited	68083-263
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration	Baxter Healthcare Corporation	43066-154
Ropivacaine Hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration	Baxter Healthcare Corporation	43066-152