Prescription drug · ANDA
Lidocaine NDC 51004-2105
lidocaine hydrochloride and epinephrine bitartrate · Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL · Injection, Solution · Submucosal · Novocol Pharmaceutical of Canada, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51004-2105-0 | 51004210500 | 50 CARTRIDGE in 1 CARTON (51004-2105-0) / 1.7 mL in 1 CARTRIDGEMarketed from Mar 18, 2019 |
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)
- Lidocaine
- Generic name (nonproprietary)
- lidocaine hydrochloride and epinephrine bitartrate
- Active ingredients
- Lidocaine hydrochloride — 20 mg/mLEpinephrine bitartrate — .01 mg/mL
- Dosage form
- Injection, Solution
- Route
- Submucosal
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088390
- 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 51004-2105_d1233ce4-5401-402f-b434-7999af2edc40SPL ID d1233ce4-5401-402f-b434-7999af2edc40SPL set ID 2005680a-8a23-4403-a618-e4ee74fa1121RxCUI 1293648UNII V13007Z41A, 30Q7KI53AK
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic; 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
N451004210500followed by a unit qualifier and the quantityPackage 51004-2105-00. 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)
INDICATIONS AND USAGE Lidocaine and Epinephrine Injection, USP is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques. Only accepted procedures for these techniques as described in standard textbooks are recommended.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 088390
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 |
|---|---|---|---|---|
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Patterson Dental | 50227-1030 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-210 |
| Xylocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate 10 ug/mL | Injection, SolutionSubmucosal | Dentsply Pharmaceutical | 66312-176 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Benco Dental | 66975-425 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Henry Schein Inc. | 0404-6512 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Safco Dental Supply Co | 67239-0240 |
| Lidocainelidocaine hydrochloride and epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Septodont, Inc. | 0362-0898 |
| Lignospan Standardlidocaine hydrochloride and epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Septodont, Inc. | 0362-1095 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Darby Dental Supply, LLC | 66467-9730 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | NDC, Inc. | 43128-105 |