Prescription drug · NDA AUTHORIZED GENERIC
Articaine NDC 51004-0102
articaine hydrochloride and epinephrine · Articaine 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 |
|---|---|---|---|
| 51004-0102-5 | 51004010205 | 50 CARTRIDGE in 1 CARTON (51004-0102-5) / 1.7 mL in 1 CARTRIDGEMarketed from Dec 4, 2015 |
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
- Generic name (nonproprietary)
- articaine hydrochloride and epinephrine
- Active ingredients
- Articaine hydrochloride — 40 mg/mLEpinephrine bitartrate — .005 mg/mL
- Dosage form
- Injection, Solution
- Route
- Submucosal
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020971
- 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 51004-0102_12371edc-1b65-424a-9979-4f765801e13bSPL ID 12371edc-1b65-424a-9979-4f765801e13bSPL set ID fc908011-5e5e-459a-a666-d41426504703RxCUI 1595029UNII QS9014Q792, 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
N451004010205followed by a unit qualifier and the quantityPackage 51004-0102-05. 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 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.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020971
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 |
|---|---|---|---|---|
| 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 .01 mg/mL | Injection, SolutionSubmucosal | Patterson Dental | 50227-1040 |
| Articadentarticaine hydrochloride and epinephrine bitartrate | Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Dentsply Pharmaceutical | 66312-601 |
| 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 | 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 |
| Zorcainearticaine hydrochloride and epinephrine | Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Septodont, Inc. | 0362-0830 |
| 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 .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 |
| Articaine Hydrochloride and Epinephrine | Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Novocol Pharmaceutical of Canada, Inc. | 51004-6620 |
| Articainearticaine hydrochloride and epinephrine | Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL | Injection, SolutionSubmucosal | Novocol Pharmaceutical of Canada, Inc. | 51004-4185 |
| 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 |
| 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 |
| Septocaine and Epinephrinearticaine hydrochloride and epinephrine bitartrate | Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Septodont Inc. | 0362-9049 |