Prescription drug · ANDA
POLOCAINE (MEPIVACAINE HCl) NDC 51662-1535
Mepivacaine hydrochloride 20 mg/mL · Injection, Solution · Infiltration · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1535-3 | 51662153503 | 21 POUCH in 1 BOX (51662-1535-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1535-2) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from May 10, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 (MEPIVACAINE HCl)
- Generic name (nonproprietary)
- polocaine (mepivacaine hcl)
- Active ingredients
- Mepivacaine hydrochloride — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Infiltration
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089410
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 51662-1535_1034d0b4-c691-2b1c-e063-6394a90a6d8eSPL ID 1034d0b4-c691-2b1c-e063-6394a90a6d8eSPL set ID c20406a6-5611-59e4-e053-2995a90a3c8fRxCUI 1012737UNII 4VFX2L7EM5UPC 0363323296018
- 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
N451662153503followed by a unit qualifier and the quantityPackage 51662-1535-03. 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 & 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: See DOSAGE AND ADMINISTRATION for additional information. Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mepivacaine. INDICATIONS
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 089410
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 |
|---|---|---|---|---|
| Polocainemepivacaine hydrochloride | Mepivacaine hydrochloride 20 mg/mL | Injection, SolutionInfiltration | Fresenius Kabi USA, LLC | 63323-296 |