What is NDC 63323-286?

63323-286 is the product NDC for Naropin (ropivacaine hydrochloride), Ropivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Naropin (Ropivacaine hydrochloride).

Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Naropin?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Naropin NDC 63323-286 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-286Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0286Add 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
63323-286-00	6332302860063323028600	12 BOTTLE in 1 CASE (63323-286-00) / 100 mL in 1 BOTTLE (63323-286-03)Marketed from May 31, 2011
63323-286-20	6332302862063323028620	5 AMPULE in 1 BOX (63323-286-20) / 20 mL in 1 AMPULE (63323-286-01)Marketed from May 31, 2011
63323-286-23	6332302862363323028623	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-23) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-286-05)Marketed from May 31, 2011
63323-286-30	6332302863063323028630	1 VIAL, SINGLE-DOSE in 1 BOX (63323-286-30) / 30 mL in 1 VIAL, SINGLE-DOSEMarketed from May 31, 2011
63323-286-31	6332302863163323028631	5 VIAL, SINGLE-DOSE in 1 BOX (63323-286-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-09)Marketed from May 31, 2011
63323-286-35	6332302863563323028635	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-35) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-11)Marketed from May 31, 2011
63323-286-63	6332302866363323028663	12 BOTTLE in 1 CASE (63323-286-63) / 200 mL in 1 BOTTLE (63323-286-33)Marketed from May 31, 2011

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): Naropin
Generic name (nonproprietary): ropivacaine hydrochloride
Active ingredients: Ropivacaine hydrochloride — 5 mg/mL
Dosage form: Injection, Solution
Route: Epidural, Infiltration, Perineural
Labeler: Fresenius Kabi USA, LLCNDC labeler code 63323
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020533
Marketing start: Sep 24, 1996
Listing expires: Dec 31, 2027
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 63323-286_cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9SPL ID cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9SPL set ID 23d2d448-a744-4877-9f2d-7e57c198da89RxCUI 905189, 905191, 1734084, 1734086, 1734090, 1734091, 1734203, 1734204, 1734207, 1734208, 1734347, 1734348, 1734355, 1734356, 1734475, 1734476, 1734479, 1734480, 1734481, 1734482, 1734483, 1734484UNII V910P86109UPC 0363323286033, 0363323285074, 0363323285036, 0363323285579, 0363323287030, 0363323286095, 0363323288075, 0363323286330, 0363323286057, 0363323288037, 0363323286118, 0363323285517
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

N463323028600 followed by a unit qualifier and the quantity

Package 63323-0286-00. 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 6, 2024.

Indications (excerpt from the label)

NAROPIN 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 NAROPIN is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesi a: epidural block for surgery including cesarean section; major nerve block; local infiltration Acute Pain Management : epidural continuous infusion or intermittent bolus, e.g…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63323-286

What is NDC 63323-286?: 63323-286 is the product NDC for Naropin (ropivacaine hydrochloride), Ropivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Naropin (Ropivacaine hydrochloride).
What is the active ingredient?: Ropivacaine hydrochloride.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Naropin?: 4 other product NDCs are listed under this name. See all Naropin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Naropin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Naropinropivacaine hydrochloride	Ropivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Infiltration, Perineural	Henry Schein, Inc.	0404-9924	00404-9924-30
Naropinropivacaine hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration	Fresenius Kabi USA, LLC	63323-285	63323-0285-67
Naropinropivacaine hydrochloride	Ropivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Perineural	Fresenius Kabi USA, LLC	63323-287	63323-0287-2063323-0287-21
Naropinropivacaine hydrochloride	Ropivacaine hydrochloride 10 mg/mL	Injection, SolutionEpidural	Fresenius Kabi USA, LLC	63323-288	63323-0288-27

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
Product	Strength	Form · route	Labeler	Product NDC
Naropinropivacaine hydrochloride	Ropivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Infiltration, Perineural	Henry Schein, Inc.	0404-9924
Naropinropivacaine hydrochloride	Ropivacaine hydrochloride 2 mg/mL	Injection, SolutionEpidural, Infiltration	Fresenius Kabi USA, LLC	63323-285
Naropinropivacaine hydrochloride	Ropivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Perineural	Fresenius Kabi USA, LLC	63323-287
Naropinropivacaine hydrochloride	Ropivacaine hydrochloride 10 mg/mL	Injection, SolutionEpidural	Fresenius Kabi USA, LLC	63323-288

Naropin (Ropivacaine hydrochloride) NDC 63323-286

NDC codes

Product information

Billing references

Product label

About NDC 63323-286

Other NDCs under NDA 020533

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NDC codes

Product information

Billing references

Product label

About NDC 63323-286

Related NDCs: other Naropin products

Other NDCs under NDA 020533