Citanest Forte DENTAL NDC 66312-580

NDC codes

FDA NDC Directory

Product NDC (as listed)66312-580Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66312-0580Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
66312-580-16	66312058016	50 CARTRIDGE in 1 CARTON (66312-580-16) / 1.8 mL in 1 CARTRIDGEMarketed from Dec 4, 2017

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 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
Labeler: Dentsply Pharmaceutical Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078959
Marketing start: Dec 4, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 66312-580_9ea4e9ed-3979-422b-b516-6b3c32459a62SPL ID 9ea4e9ed-3979-422b-b516-6b3c32459a62SPL set ID 60c8710b-ae55-4fdf-e053-2991aa0adc75RxCUI 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

N466312058016 followed by a unit qualifier and the quantity

Package 66312-0580-16. 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 Feb 29, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078959

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078959
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	Novocol Pharmaceutical of Canada, Inc.	51004-5801