Prescription drug · NDA AUTHORIZED GENERIC
Articaine Hydrochloride and Epinephrine NDC 0404-6625
Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL · Injection, Solution · Submucosal · Henry Schein
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0404-6625Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00404-6625Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-6625-05 | 0040466250500404662505 | 50 CARTRIDGE in 1 CARTON (0404-6625-05) / 1.7 mL in 1 CARTRIDGEMarketed from Jan 28, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 and epinephrine
- Active ingredients
- Articaine hydrochloride — 40 mg/mLEpinephrine bitartrate — .005 mg/mL
- Dosage form
- Injection, Solution
- Route
- Submucosal
- Labeler
- Henry ScheinNDC labeler code 0404
- 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 0404-6625_67eba8ba-c8c4-43f5-a482-88e4c0c355a8SPL ID 67eba8ba-c8c4-43f5-a482-88e4c0c355a8SPL set ID d9402ac2-fedd-4fb0-90a3-2c466a786526RxCUI 1595029, 1595035UNII 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
N400404662505followed by a unit qualifier and the quantityPackage 00404-6625-05. 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.
About NDC 0404-6625
- What is NDC 0404-6625?
- 0404-6625 is the product NDC for Articaine Hydrochloride and Epinephrine, Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate .005 mg/mL injection, solution, listed with the FDA by Henry Schein. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Articaine Hydrochloride and Epinephrine.
- What is the active ingredient?
- Articaine hydrochloride, Epinephrine bitartrate.
- Who is the labeler?
- Henry Schein, NDC labeler code 0404. 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.
Related NDCs: other Articaine Hydrochloride and Epinephrine products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 Epinephrinearticaine hydrochloride, epinephrine bitartrate | Articaine hydrochloride 40 mg/mL; Epinephrine bitartrate 5 ug/mL | Injection, SolutionSubmucosal | Burkhart Dental Supply Co., Inc | 43498-993 | 43498-0993-01 |
| 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 | Novocol Pharmaceutical of Canada, Inc. | 51004-6625 | 51004-6625-05 |
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 |
|---|---|---|---|---|
| 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 | 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 .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 |