Prescription drug · ANDA
Lignospan Forte (Lidocaine hydrochloride and epinephrine) NDC 0362-1096
Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mL · Injection, Solution · Submucosal · Septodont, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0362-1096-70 | 0036210967000362109670 | 5 BLISTER PACK in 1 CARTON (0362-1096-70) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGEMarketed from Dec 1, 2017 |
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)
- Lignospan Forte
- Generic name (nonproprietary)
- lidocaine hydrochloride and epinephrine
- Active ingredients
- Lidocaine hydrochloride — 20 mg/mLEpinephrine bitartrate — .02 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 088389
- 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 0362-1096_cb2397ba-49a9-4c95-bbde-17d1260607eeSPL ID cb2397ba-49a9-4c95-bbde-17d1260607eeSPL set ID f8ca7d03-01c8-450f-9279-59789c3497eaRxCUI 1011814, 1657026UNII 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
N400362109670followed by a unit qualifier and the quantityPackage 00362-1096-70. 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 LIGNOSPAN 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 0362-1096
- What is NDC 0362-1096?
- 0362-1096 is the product NDC for Lignospan Forte, Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 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?
- Lignospan Forte (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 Lignospan Forte?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 088389
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 | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mL | Injection, SolutionSubmucosal | Septodont, Inc. | 0362-0262 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mL | Injection, SolutionSubmucosal | Henry Schein Inc. | 0404-6500 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mL | Injection, SolutionSubmucosal | Patterson Dental | 50227-1020 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mL | Injection, SolutionSubmucosal | Darby Dental Supply, LLC | 66467-9710 |
| Lidocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate .02 mg/mL | Injection, SolutionSubmucosal | Benco Dental | 66975-415 |
| Xylocainelidocaine hydrochloride and epinephrine bitartrate | Lidocaine hydrochloride 20 mg/mL; Epinephrine bitartrate 20 ug/mL | Injection, SolutionSubmucosal | Dentsply Pharmaceutical | 66312-181 |