Prescription drug · NDA
Flavalta NDC 0362-1200
lidocaine hydrochloride and epinephrine · 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 |
|---|---|---|---|
| 0362-1200-50 | 00362120050 | 50 CARTRIDGE in 1 CARTON (0362-1200-50) / 1.7 mL in 1 CARTRIDGEMarketed from Mar 19, 2026 |
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)
- Flavalta
- 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.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216564
- 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 0362-1200_6ec4f11a-4a43-4a5b-8072-eefcc695b4beSPL ID 6ec4f11a-4a43-4a5b-8072-eefcc695b4beSPL set ID 3f9f9b4f-bf6c-4b57-ac1a-98fd1a9a369dRxCUI 1293648, 2739501UNII 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
N400362120050followed by a unit qualifier and the quantityPackage 00362-1200-50. 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)
FLAVALTA solution is indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques [see Dosage and Administration (2.2) ]. FLAVALTA solution is a combination of lidocaine, an amide local anesthetic, and epinephrine, an alpha and beta adrenergic agonist indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques.
Excerpt only. Read the full label for complete information.