Prescription drug · ANDA
Lidocaine (Lidocaine hydrochloride and epinephrine) NDC 0362-0898
Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL · Injection, Solution · Submucosal · Septodont, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0362-0898-05 | 0036208980500362089805 | 50 CARTRIDGE in 1 CARTON (0362-0898-05) / 1.7 mL in 1 CARTRIDGEMarketed from Jul 18, 2018 |
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)
- Lidocaine
- Generic name (nonproprietary)
- lidocaine hydrochloride and epinephrine
- Active ingredients
- Lidocaine hydrochloride — 20 mg/mLEpinephrine bitartrate — .01 mg/mL
- Dosage form
- Injection, Solution
- Route
- Submucosal
- Labeler
- Septodont, Inc.NDC labeler code 0362
- 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 0362-0898_245e96e1-06d2-4cfa-ba0e-cd338222ec27SPL ID 245e96e1-06d2-4cfa-ba0e-cd338222ec27SPL set ID 864e511b-cc50-4ed9-b122-8e1a93457332RxCUI 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
N400362089805followed by a unit qualifier and the quantityPackage 00362-0898-05. 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)
INDICATIONS AND USAGE Lidocaine hydrochloride and epinephrine injection, USP solutions are 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.
About NDC 0362-0898
- What is NDC 0362-0898?
- 0362-0898 is the product NDC for Lidocaine, Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL injection, solution, listed with the FDA by Septodont, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidocaine (Lidocaine Hydrochloride and Epinephrine).
- What is the active ingredient?
- Lidocaine hydrochloride, Epinephrine bitartrate.
- Who is the labeler?
- Septodont, Inc., NDC labeler code 0362. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lidocaine?
- 157 other product NDCs are listed under this name. See all Lidocaine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidocaine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Direct_Rx | 72189-692 | 72189-0692-50 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-4195 | 68788-4195-05 |
| Lidocaine | Lidocaine 50 mg/g | PatchTopical | Ascend Laboratories, LLC | 67877-767 | 67877-0767-30 |
| Lidocaine | Lidocaine 80 mg/mL | SprayTopical | YYBA CORP | 73581-900 | 73581-0900-01 |
| Lidocaine | Lidocaine 50 mg/g | OintmentTopical | Advanced Rx of Tennessee, LLC | 80425-0594 | 80425-0594-01 |
| Lidocainelidocaine hydrochloride | Lidocaine hydrochloride 20 mg/mL | JellyTopical | Sentiss Pharmaceuticals LLC | 70244-039 | 70244-0039-0170244-0039-02 |
| Lidocaine | Lidocaine 100 kg/100kg | GranuleTopical | Shaanxi Shuvita Biotech Co., Ltd | 87879-002 | 87879-0002-02 |
| Lidocainelidicaine | Lidocaine 50 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-107 | 21922-0107-1321922-0107-61 |
| Lidocaine | Lidocaine hydrochloride 50 mg/mL | GelTopical | YYBA Corp | 73581-115 | 73581-0115-03 |
| Lidocaine | Lidocaine 5 g/100mL | CreamTopical | YYBA Corp | 73581-022 | 73581-0022-06 |
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 | Henry Schein Inc. | 0404-6512 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | NDC, Inc. | 43128-105 |
| 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 | Novocol Pharmaceutical of Canada, Inc. | 51004-2105 |
| 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 | Benco Dental | 66975-425 |
| 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 bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | The Atlanta Dental Supply Company DBA Advanced Dental Products | 71347-210 |
| Lignospan Standardlidocaine hydrochloride and epinephrine | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .01 mg/mL | Injection, SolutionSubmucosal | Septodont, Inc. | 0362-1095 |
| Xylocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate 10 ug/mL | Injection, SolutionSubmucosal | Dentsply Pharmaceutical | 66312-176 |