Citanest Plain
- Product NDC
- 66312-630
- 11-digit product format
- 663120630
- Labeler code
- 66312
- Product ID
- 66312-630_14eaeca2-d602-48eb-a384-eee02a9a1b04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prilocaine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBMUCOSAL
- Labeler
- Dentsply Pharmaceutical Inc.
- Application
- ANDA079235
- Marketing category
- ANDA
- Marketing start
- 1965-11-18
- Substance
- PRILOCAINE HYDROCHLORIDE
- Active strength
- 40 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
- Citanest Plain
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRILOCAINE HYDROCHLORIDE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MJW015BAPH |
| Rxcui | 1012706, 1595048 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66312-630-14 | Citanest Plain | 50 in 1 CARTON | INJECTION, SOLUTION | 50 | | 8 |
| 66312-630-14 | Citanest Plain | 1.8 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1.8 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66312-630 | CITANEST PLAIN (PRILOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [DENTSPLY PHARMACEUTICAL INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20211113_db23a56f-1e41-4843-9220-1b2e3059db41.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 |
|---|
| 66312-630-14 | 66312063014 | 50 CARTRIDGE in 1 CARTON (66312-630-14) / 1.8 mL in 1 CARTRIDGE | 50 cartridge | 1965-11-18 | 0000-00-00 | No | No | Current |