Prescription drug · ANDA
Polocaine (Mepivacaine hydrochloride) NDC 66312-441
Mepivacaine hydrochloride 30 mg/mL · Injection, Solution · Submucosal · Dentsply Pharmaceutical
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66312-441-16 | 6631204411666312044116 | 50 CARTRIDGE in 1 CARTON (66312-441-16) / 1.7 mL in 1 CARTRIDGEMarketed from Oct 10, 1984 |
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 — 30 mg/mL
- Dosage form
- Injection, Solution
- Route
- Submucosal
- Labeler
- Dentsply PharmaceuticalNDC labeler code 66312
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088387
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 66312-441_fc3879ee-0f0f-40d9-b127-12001b54b998SPL ID fc3879ee-0f0f-40d9-b127-12001b54b998SPL set ID 25074a6a-7f67-4ad8-86e0-2afe23ec5d04RxCUI 1012756, 1305263UNII 4VFX2L7EM5
- 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
N466312044116followed by a unit qualifier and the quantityPackage 66312-0441-16. 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 Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.
Excerpt only. Read the full label for complete information.
About NDC 66312-441
- What is NDC 66312-441?
- 66312-441 is the product NDC for Polocaine (mepivacaine hydrochloride), Mepivacaine hydrochloride 30 mg/mL injection, solution, listed with the FDA by Dentsply Pharmaceutical. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Polocaine (Mepivacaine Hydrochloride).
- What is the active ingredient?
- Mepivacaine hydrochloride.
- Who is the labeler?
- Dentsply Pharmaceutical, NDC labeler code 66312. 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?
- 3 other product NDCs are listed under this name. See all Polocaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Polocaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Polocainemepivacaine hydrochloride | Mepivacaine hydrochloride 10 mg/mL | Injection, SolutionInfiltration | Fresenius Kabi USA, LLC | 63323-283 | 63323-0283-57 |
| Polocainemepivacaine hydrochloride | Mepivacaine hydrochloride 20 mg/mL | Injection, SolutionInfiltration | Fresenius Kabi USA, LLC | 63323-296 | 63323-0296-57 |
| Polocainemepivacaine hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | Novocol Pharmaceutical of Canada Inc. | 51004-4411 | 51004-4411-06 |
Other NDCs under ANDA 088387
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 |
|---|---|---|---|---|
| Carbocainemepivacaine hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | Septodont, Inc. | 0362-0753 |
| Mepivacainemepivacaine hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | NDC, Inc. | 43128-005 |
| Mepivacainemepivacaine hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | Patterson Dental Supply, Inc. | 50227-1080 |
| Mepivacainemepivacaine hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | Novocol Pharmaceutical of Canada, Inc. | 51004-0005 |
| Mepivacainemepivacaine hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | Darby Dental Supply, LLC | 66467-9760 |
| Mepivacainemepivacaine hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | Benco Dental | 66975-406 |
| Mepivacaine Hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | Henry Schein Inc. | 0404-6730 |
| Mepivacaine Hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | Safco Dental Supply Co. | 67239-0201 |
| Polocainemepivacaine hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubmucosal | Novocol Pharmaceutical of Canada Inc. | 51004-4411 |
| Scandonest 3% Plainmepivacaine hydrochloride | Mepivacaine hydrochloride 30 mg/mL | Injection, SolutionSubcutaneous | Septodont, Inc. | 0362-1098 |