Prescription drug · NDA AUTHORIZED GENERIC
Articaine HCl and Epinephrine NDC 67239-0209
articaine hydrochloride and epinephrine bitartrate · Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 10 ug/mL · Injection · Submucosal · Safco Dental Supply Co.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67239-0209-1 | 67239020901 | 50 CARTRIDGE in 1 CARTON (67239-0209-1) / 1.8 mL in 1 CARTRIDGEMarketed from Jun 1, 2016 |
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)
- Articaine HCl and Epinephrine
- Generic name (nonproprietary)
- articaine hydrochloride and epinephrine bitartrate
- Active ingredients
- Articaine hydrochloride — 40 mg/mLEpinephrine bitartrate — 10 ug/mL
- Dosage form
- Injection
- Route
- Submucosal
- Labeler
- Safco Dental Supply Co.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022466
- 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 67239-0209_253a3ea1-c583-49d4-9655-b33ffa1115b0SPL ID 253a3ea1-c583-49d4-9655-b33ffa1115b0SPL set ID 0536a4de-578d-497e-a01b-0b1887344cc8RxCUI 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
N467239020901followed by a unit qualifier and the quantityPackage 67239-0209-01. 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 .
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 and older. Articaine HCl and Epinephrine is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022466
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 |
|---|---|---|---|---|
| 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 |
| 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 | Pierrel S.p.A. | 45146-110 |
| 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 |
| Articaine Hydrochloride and Epinephrinearticaine hydrochloride, epinephrine bitartrate | Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL | Injection, SolutionSubmucosal | Burkhart Dental Supply Co., Inc | 43498-993 |
| 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 |
- openFDA data updated
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