Home NDC 0362-1200 Flavalta
Product NDC 0362-1200
11-digit product format 003621200
Labeler code 0362
Product ID 0362-1200_6ec4f11a-4a43-4a5b-8072-eefcc695b4be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine Hydrochloride and Epinephrine
Dosage form INJECTION, SOLUTION
Route SUBMUCOSAL
Labeler Septodont, Inc.
Application NDA216564
Marketing category NDA
Marketing start 2026-03-19
Substance EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
Active strength .01; 20 mg/mL; mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216564-001 FLAVALTA EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML) SOLUTION / INJECTION RLD, RS 2026-03-19
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216564-001 FLAVALTA EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML) SOLUTION / INJECTION RLD, RS 2026-03-19 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Flavalta
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE .01 mg/mL EPINEPHRINE BITARTRATE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup 30Q7KI53AK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1293648 Internal RxNorm lookup 2739501 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0362-1200-50 Flavalta 50 in 1 CARTON INJECTION, SOLUTION 50 2 0362-1200-50 Flavalta 1.7 mL in 1 CARTRIDGE INJECTION, SOLUTION 1.7 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Flavalta LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE Septodont, Inc. 3f9f9b4f-bf6c-4b57-ac1a-98fd1a9a369d 2026-03-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 216564 application number: NDA216564 ndc (product): 0362-1200
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0362-1200-50 00362120050 50 CARTRIDGE in 1 CARTON (0362-1200-50) / 1.7 mL in 1 CARTRIDGE 50 cartridge 2026-03-19 No No Current