Prescription drug · ANDA
Polocaine-MPF (Mepivacaine hydrochloride) NDC 63323-260
Mepivacaine hydrochloride 10 mg/mL · Injection, Solution · Epidural, Infiltration · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-260-37 | 6332302603763323026037 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-260-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-260-01)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-MPF
- Generic name (nonproprietary)
- mepivacaine hydrochloride
- Active ingredients
- Mepivacaine hydrochloride — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089406
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 63323-260_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
N463323026037followed by a unit qualifier and the quantityPackage 63323-0260-37. 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.
About NDC 63323-260
- What is NDC 63323-260?
- 63323-260 is the product NDC for Polocaine-MPF (mepivacaine hydrochloride), Mepivacaine hydrochloride 10 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Polocaine-MPF (Mepivacaine hydrochloride).
- What is the active ingredient?
- Mepivacaine 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 Polocaine-MPF?
- 2 other product NDCs are listed under this name. See all Polocaine-MPF NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Polocaine-MPF products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Polocaine-MPFmepivacaine hydrochloride | Mepivacaine hydrochloride 15 mg/mL | Injection, SolutionEpidural, Infiltration | Fresenius Kabi USA, LLC | 63323-293 | 63323-0293-37 |
| Polocaine-MPFmepivacaine hydrochloride | Mepivacaine hydrochloride 20 mg/mL | Injection, SolutionEpidural, Infiltration | Fresenius Kabi USA, LLC | 63323-294 | 63323-0294-27 |
Other NDCs under ANDA 089406
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Polocaine(R) -Mpf (Mepivacaine Hci) | Mepivacaine hydrochloride 10 mg/mL | Injection, SolutionEpidural, Infiltration | HF Acquisition Co LLC, DBA HealthFirst | 51662-1403 |