Polocaine (mepivacaine hydrochloride) NDC 63323-283

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-283Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0283Add 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
63323-283-57	63323028357	25 VIAL, MULTI-DOSE in 1 TRAY (63323-283-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-283-01)Marketed from Jul 20, 2009

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): Polocaine
Generic name (nonproprietary): mepivacaine hydrochloride
Active ingredients: Mepivacaine hydrochloride — 10 mg/mL
Dosage form: Injection, Solution
Route: Infiltration
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089407
Marketing start: Jul 20, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 63323-283_b3d50315-0f09-4294-a788-990036dfc45cSPL ID b3d50315-0f09-4294-a788-990036dfc45cSPL set ID a27d0815-ae6b-4a21-a8f5-564c01e83814RxCUI 1012722, 1012726, 1012731, 1012735, 1012737, 1012741, 1866503, 1866515, 1866524, 1866531UNII 4VFX2L7EM5UPC 0363323260019, 0363323296018, 0363323283018, 0363323293017, 0363323294014
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

N463323028357 followed by a unit qualifier and the quantity

Package 63323-0283-57. 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 Oct 1, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE: POLOCAINE (Mepivacaine HCl Injection, USP), is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural techniques including epidural and caudal blocks. The routes of administration and indicated concentrations for mepivacaine are: local infiltration 0.5% (via dilution) or 1 % peripheral nerve blocks 1% and 2% epidural block 1%, 1.5%, 2% caudal block 1%, 1.5%, 2% See DOSAGE AND ADMINISTRATION for additional information. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mepivacaine.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 089407

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

FDA NDC Directory listings under ANDA 089407
Product	Strength	Form · route	Labeler	Product NDC
POLOCAINE (MEPIVACAINE HCl)	Mepivacaine hydrochloride 10 mg/mL	Injection, SolutionInfiltration	HF Acquisition Co LLC, DBA HealthFirst	51662-1534