Prescription drug · ANDA
Polocaine-MPF (mepivacaine hydrochloride) NDC 63323-294
Mepivacaine hydrochloride 20 mg/mL · Injection, Solution · Epidural, Infiltration · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-294-27 | 63323029427 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-294-27) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-294-01)Marketed from Jul 21, 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-MPF
- Generic name (nonproprietary)
- mepivacaine hydrochloride
- Active ingredients
- Mepivacaine hydrochloride — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089409
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 63323-294_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
N463323029427followed by a unit qualifier and the quantityPackage 63323-0294-27. 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)
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.