Home NDC 0264-9378 LIDOCAINE HCl and EPINEPHRINE
Product NDC 0264-9378
11-digit product format 002649378
Labeler code 0264
Product ID 0264-9378_5f189f9b-1978-401e-8e5f-1969fe8c8ad7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LIDOCAINE HCl and EPINEPHRINE
Dosage form INJECTION
Route EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler B. Braun Medical Inc.
Application ANDA208475
Marketing category ANDA
Marketing start 2021-09-08
Substance EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength .005; 15 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 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 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE EPINEPHRINE; LIDOCAINE HYDROCHLORIDE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208475-001 AP
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 2026-02-19 14:30 UTC 2026-02 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base LIDOCAINE HCl and EPINEPHRINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE ANHYDROUS .005 mg/mL EPINEPHRINE BITARTRATE 15 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EC2CNF7XFP Internal UNII lookup 30Q7KI53AK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1867998 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 0264-9378-05 LIDOCAINE HCl and EPINEPHRINE 5 in 1 CARTON INJECTION 5 7 0264-9378-88 LIDOCAINE HCl and EPINEPHRINE 5 mL in 1 AMPULE INJECTION 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-9378 LIDOCAINE HCL AND EPINEPHRINE INJECTION [B. BRAUN MEDICAL INC.] 7 Current NDC, Legacy NDC, 2 package rows 20211216_fc83d701-02b2-4595-8e5b-dbebc5e209d5.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 · 1 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 0264-9378-05 00264937805 5 AMPULE in 1 CARTON (0264-9378-05) / 5 mL in 1 AMPULE (0264-9378-88) 5 ampule 2021-09-08 0000-00-00 No No Current 0264-9378-88 00264937888 5 mL in 1 AMPULE 5 ml Historical