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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 2006-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION AP 2006-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077250-001 VIVACAINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077250-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.5%;0.0091MG/ML INJECTABLE / INJECTION RS 2006-09-27 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-09-15 20:21 UTC 2019-09 A077250-001 AP 1 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077250-001 AP 1 ea99ee380514…
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
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 · 2 matching rows.
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