What is NDC 66312-601?

66312-601 is the product NDC for Articadent, Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL injection, solution, listed with the FDA by Dentsply Pharmaceutical. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Articadent (Articaine hydrochloride and Epinephrine Bitartrate).

What is the active ingredient?

Articaine hydrochloride, Epinephrine bitartrate.

Dentsply Pharmaceutical, 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 Articadent?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Articadent NDC 66312-601 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)66312-601Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66312-0601Add 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
66312-601-16	6631206011666312060116	50 CARTRIDGE in 1 CARTON (66312-601-16) / 1.7 mL in 1 CARTRIDGEMarketed from Sep 1, 2009

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): Articadent
Generic name (nonproprietary): articaine hydrochloride and epinephrine bitartrate
Active ingredients: Articaine hydrochloride — 40 mg/mLEpinephrine bitartrate — .01 mg/mL
Dosage form: Injection, Solution
Route: Submucosal
Labeler: Dentsply PharmaceuticalNDC labeler code 66312
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020971
Marketing start: Sep 1, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 66312-601_7b56ec0a-5b85-4069-a3b2-94654644aaa4SPL ID 7b56ec0a-5b85-4069-a3b2-94654644aaa4SPL set ID 9ca8fb43-4f34-47c0-8b79-3b5bd1eaee00RxCUI 1011646, 1011648, 1595029, 1595035UNII 30Q7KI53AK, QS9014Q792UPC 0000004235644
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

N466312060116 followed by a unit qualifier and the quantity

Package 66312-0601-16. 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 Mar 1, 2024.

Indications (excerpt from the label)

ARTICADENT is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older. ARTICADENT is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66312-601

What is NDC 66312-601?: 66312-601 is the product NDC for Articadent, Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL injection, solution, listed with the FDA by Dentsply Pharmaceutical. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Articadent (Articaine hydrochloride and Epinephrine Bitartrate).
What is the active ingredient?: Articaine hydrochloride, Epinephrine bitartrate.
Who is the labeler?: Dentsply Pharmaceutical, 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 Articadent?: 1 other product NDC are listed under this name. See all Articadent NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Articadent NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Articadentarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Dentsply Pharmaceutical	66312-602	66312-0602-16

Other NDCs under NDA 020971

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

FDA NDC Directory listings under NDA 020971
Product	Strength	Form · route	Labeler	Product NDC
Articadentarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Dentsply Pharmaceutical	66312-602
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	NDC, Inc.	43128-101
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	NDC, Inc.	43128-102
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Patterson Dental	50227-1040
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Patterson Dental	50227-1050
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Novocol Pharmaceutical of Canada, Inc.	51004-0102
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Novocol Pharmaceutical of Canada, Inc.	51004-1010
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Novocol Pharmaceutical of Canada, Inc.	51004-1040
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Novocol Pharmaceutical of Canada, Inc.	51004-4175
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Novocol Pharmaceutical of Canada, Inc.	51004-4185
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Benco Dental	66975-417
Articainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Benco Dental	66975-418
Articaine Hydrochloride and Epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Henry Schein	0404-6620
Articaine Hydrochloride and Epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Henry Schein	0404-6625
Articaine Hydrochloride and Epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Novocol Pharmaceutical of Canada, Inc.	51004-6620
Articaine Hydrochloride and Epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Novocol Pharmaceutical of Canada, Inc.	51004-6625
Septocaine and Epinephrinearticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Septodont Inc.	0362-9048
Septocaine and Epinephrinearticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Septodont Inc.	0362-9049
Zorcainearticaine hydrochloride and epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Septodont, Inc.	0362-0830