Prescription drug · ANDA
Citanest Plain (Prilocaine hydrochloride) NDC 66312-630
Prilocaine hydrochloride 40 mg/mL · Injection, Solution · Submucosal · Dentsply Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66312-630-14 | 66312063014 | 50 CARTRIDGE in 1 CARTON (66312-630-14) / 1.8 mL in 1 CARTRIDGEMarketed from Nov 18, 1965 |
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)
- Citanest Plain
- Generic name (nonproprietary)
- prilocaine hydrochloride
- Active ingredients
- Prilocaine hydrochloride — 40 mg/mL
- Dosage form
- Injection, Solution
- Route
- Submucosal
- Labeler
- Dentsply Pharmaceutical Inc.NDC labeler code 66312
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079235
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 66312-630_14eaeca2-d602-48eb-a384-eee02a9a1b04SPL ID 14eaeca2-d602-48eb-a384-eee02a9a1b04SPL set ID db23a56f-1e41-4843-9220-1b2e3059db41RxCUI 1012706, 1595048UNII MJW015BAPH
- 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
N466312063014followed by a unit qualifier and the quantityPackage 66312-0630-14. 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 4% Citanest Plain Dental Injection, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.
Excerpt only. Read the full label for complete information.
About NDC 66312-630
- What is NDC 66312-630?
- 66312-630 is the product NDC for Citanest Plain (prilocaine hydrochloride), Prilocaine hydrochloride 40 mg/mL injection, solution, listed with the FDA by Dentsply Pharmaceutical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Citanest Plain (Prilocaine hydrochloride).
- What is the active ingredient?
- Prilocaine hydrochloride.
- Who is the labeler?
- Dentsply Pharmaceutical Inc., 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 Citanest Plain?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.