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

Additional Listing Data#

Finished product
Yes
Brand name base
LIDOCAINE HCl and EPINEPHRINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE BITARTRATE.005 mg/mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK, EC2CNF7XFP
Rxcui1867998

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-9378-05LIDOCAINE HCl and EPINEPHRINE5 in 1 CARTONINJECTION57
0264-9378-88LIDOCAINE HCl and EPINEPHRINE5 mL in 1 AMPULEINJECTION57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-9378LIDOCAINE HCL AND EPINEPHRINE INJECTION [B. BRAUN MEDICAL INC.]7Current NDC, Legacy NDC, 2 package rows20211216_fc83d701-02b2-4595-8e5b-dbebc5e209d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 in 5 ML InjectionPSNfc83d701-02b2-4595-8e5b-dbebc5e209d57
18679985 ML epinephrine 0.005 MG/ML / lidocaine hydrochloride 15 MG/ML InjectionSCDfc83d701-02b2-4595-8e5b-dbebc5e209d57
1867998lidocaine HCl 1.5 % / EPINEPHrine 1:200,000 per 5 ML InjectionSYfc83d701-02b2-4595-8e5b-dbebc5e209d57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-9378-05002649378055 AMPULE in 1 CARTON (0264-9378-05) / 5 mL in 1 AMPULE (0264-9378-88) 5 ampule2021-09-080000-00-00NoNoCurrent
0264-9378-88002649378885 mL in 1 AMPULE5 mlHistorical