Polocaine
- Product NDC
- 66312-441
- 11-digit product format
- 663120441
- Labeler code
- 66312
- Product ID
- 66312-441_fc3879ee-0f0f-40d9-b127-12001b54b998
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mepivacaine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Dentsply Pharmaceutical
- Application
- ANDA088387
- Marketing category
- ANDA
- Marketing start
- 1984-10-10
- Substance
- MEPIVACAINE HYDROCHLORIDE
- Active strength
- 30 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Polocaine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEPIVACAINE HYDROCHLORIDE | 30 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4VFX2L7EM5 |
| Rxcui | 1012756, 1305263 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66312-441-16 | Polocaine | 1.7 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.7 | | 9 |
| 66312-441-16 | Polocaine | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66312-441 | POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240223_25074a6a-7f67-4ad8-86e0-2afe23ec5d04.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66312-441-16 | 66312044116 | 50 CARTRIDGE in 1 CARTON (66312-441-16) / 1.7 mL in 1 CARTRIDGE | 50 cartridge | 1984-10-10 | 0000-00-00 | No | No | Current |