Home NDC 0362-0557 Marcaine
Product NDC 0362-0557
11-digit product format 003620557
Labeler code 0362
Product ID 0362-0557_2095bcd0-0dc6-4b6e-a86c-23140421e3d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bupivacaine hydrochloride and epinephrine bitartrate
Dosage form INJECTION, SOLUTION
Route SUBMUCOSAL
Labeler Septodont, Inc.
Application ANDA077250
Marketing category ANDA
Marketing start 2018-06-12
Substance BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
Active strength 5; .005 mg/mL; mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A077250-001 VIVACAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27
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 2026-08-01 22:54:32 2026-06 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Marcaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg/mL EPINEPHRINE BITARTRATE .005 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AKA908P8J1 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 1670365 Internal RxNorm lookup 1673142 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 0362-0557-05 Marcaine 50 in 1 CARTON INJECTION, SOLUTION 50 5 0362-0557-05 Marcaine 1.8 mL in 1 CARTRIDGE INJECTION, SOLUTION 1.8 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0362-0557 MARCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240217_3e196aa4-0b01-44db-9267-98a995b54743.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0362-0557-05 00362055705 50 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE 50 cartridge 2018-06-12 0000-00-00 No No Current