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 43 .
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 2026-09-14 22:38:34 2026-08 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208475-001 LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 0.005MG/ML;1.5% INJECTABLE / INJECTION AP 2021-09-08 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LIDOCAINE HCl and EPINEPHRINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE ANHYDROUS 15 mg/mL EPINEPHRINE BITARTRATE .005 mg/mL
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
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