What is NDC 43498-993?

43498-993 is the product NDC for Articaine Hydrochloride and Epinephrine, Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL injection, solution, listed with the FDA by Burkhart Dental Supply Co., Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Articaine Hydrochloride and Epinephrine (Articaine hydrochloride, Epinephrine bitartrate).

What is the active ingredient?

Articaine hydrochloride, Epinephrine bitartrate.

Burkhart Dental Supply Co., Inc, NDC labeler code 43498. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Articaine Hydrochloride and Epinephrine?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Articaine Hydrochloride and Epinephrine NDC 43498-993

NDC codes

FDA NDC Directory

Product NDC (as listed)43498-993Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43498-0993Add 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
43498-993-01	4349809930143498099301	50 CARTRIDGE in 1 BOX (43498-993-01) / 1.8 mL in 1 CARTRIDGEMarketed from Nov 4, 2024

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): Articaine Hydrochloride and Epinephrine
Generic name (nonproprietary): articaine hydrochloride, epinephrine bitartrate
Active ingredients: Articaine hydrochloride — 40 mg/mLEpinephrine bitartrate — 5 ug/mL
Dosage form: Injection, Solution
Route: Submucosal
Labeler: Burkhart Dental Supply Co., IncNDC labeler code 43498
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022466
Marketing start: Nov 4, 2024
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 43498-993_644fa9c3-1491-42e3-9194-9c562617fd06SPL ID 644fa9c3-1491-42e3-9194-9c562617fd06SPL set ID 4f11bb06-c71b-4d96-9baa-2a17ad473a05RxCUI 1658966, 1661483UNII 30Q7KI53AK, QS9014Q792
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

N443498099301 followed by a unit qualifier and the quantity

Package 43498-0993-01. 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 Nov 18, 2024.

Indications (excerpt from the label)

Articaine HCl and Epinephrine 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. Articaine HCl and Epinephrine 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 ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43498-993

What is NDC 43498-993?: 43498-993 is the product NDC for Articaine Hydrochloride and Epinephrine, Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL injection, solution, listed with the FDA by Burkhart Dental Supply Co., Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Articaine Hydrochloride and Epinephrine (Articaine hydrochloride, Epinephrine bitartrate).
What is the active ingredient?: Articaine hydrochloride, Epinephrine bitartrate.
Who is the labeler?: Burkhart Dental Supply Co., Inc, NDC labeler code 43498. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Articaine Hydrochloride and Epinephrine?: 5 other product NDCs are listed under this name. See all Articaine Hydrochloride and Epinephrine 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 Articaine Hydrochloride and Epinephrine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Articaine Hydrochloride and Epinephrinearticaine hydrochloride, epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	Injection, SolutionSubmucosal	Burkhart Dental Supply Co., Inc	43498-816	43498-0816-01
Articaine Hydrochloride and Epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Henry Schein	0404-6620	00404-6620-05
Articaine Hydrochloride and Epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL	Injection, SolutionSubmucosal	Novocol Pharmaceutical of Canada, Inc.	51004-6620	51004-6620-05
Articaine Hydrochloride and Epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Henry Schein	0404-6625	00404-6625-05
Articaine Hydrochloride and Epinephrine	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL	Injection, SolutionSubmucosal	Novocol Pharmaceutical of Canada, Inc.	51004-6625	51004-6625-05

Other NDCs under NDA 022466

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

FDA NDC Directory listings under NDA 022466
Product	Strength	Form · route	Labeler	Product NDC
Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	InjectionSubmucosal	Safco Dental Supply Co.	67239-0209
Articaine HCl and Epinephrinearticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL	InjectionSubmucosal	Safco Dental Supply Co.	67239-0210
Articaine Hydrochloride and Epinephrinearticaine hydrochloride, epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	Injection, SolutionSubmucosal	Burkhart Dental Supply Co., Inc	43498-816
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	InjectionSubmucosal	Pierrel S.p.A.	45146-110
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL	InjectionSubmucosal	Pierrel S.p.A.	45146-120
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL	InjectionSubmucosal	Aira LLC	87566-110
Orablocarticaine hydrochloride and epinephrine bitartrate	Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL	InjectionSubmucosal	Aira LLC	87566-120