Prescription drug · ANDA
Citanest Forte DENTAL NDC 51004-5801
prilocaine hcl and epinephrine · Prilocaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL · Injection, Solution · Submucosal · Novocol Pharmaceutical of Canada, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51004-5801-6 | 51004580106 | 50 CARTRIDGE in 1 CARTON (51004-5801-6) / 1.8 mL in 1 CARTRIDGEMarketed from Dec 4, 2017 |
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)
- Citanest Forte DENTAL
- Generic name (nonproprietary)
- prilocaine hcl and epinephrine
- Active ingredients
- Prilocaine hydrochloride — 40 mg/mLEpinephrine bitartrate — .005 mg/mL
- Dosage form
- Injection, Solution
- Route
- Submucosal
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078959
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 51004-5801_8f96de1c-fc45-4d2b-963c-1eadf85bd164SPL ID 8f96de1c-fc45-4d2b-963c-1eadf85bd164SPL set ID 801a4f80-397b-46c5-ad3e-a80594e7bda2RxCUI 1596950, 1993224UNII MJW015BAPH, 30Q7KI53AK
- Pharmacologic class
- Amide Local Anesthetic; Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist
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
N451004580106followed by a unit qualifier and the quantityPackage 51004-5801-06. 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 Citanest Forte 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.
Other NDCs under ANDA 078959
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 |
|---|---|---|---|---|
| Citanest Forte DENTALprilocaine hcl and epinephrine | Prilocaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionSubmucosal | Dentsply Pharmaceutical Inc. | 66312-580 |