FDA.reportPublic FDA data

Lidocaine Hydrochloride and Dextrose

Product NDC
0264-9598
11-digit product format
002649598
Labeler code
0264
Product ID
0264-9598_9e352802-107c-4f90-babe-4f69c7dc892e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA019830
Marketing category
NDA
Marketing start
1992-04-08
Substance
DEXTROSE MONOHYDRATE; LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
5; .8 g/100mL; g/100mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Hydrochloride and Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL
LIDOCAINE HYDROCHLORIDE ANHYDROUS.8 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX22YL083G, EC2CNF7XFP
Rxcui1737723, 1737742, 1737744

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0264-9598-20Lidocaine Hydrochloride and Dextrose24 in 1 CASEINJECTION, SOLUTION2419
0264-9598-20Lidocaine Hydrochloride and Dextrose250 mL in 1 CONTAINERINJECTION, SOLUTION25019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-9598-20ML - Milliliter0264-95988df11d4e-cd74-448b-9c7b-65ec4e85c14912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROSE MONOHYDRATEACTIVE INGREDIENTLX22YL083GLIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]11
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPLIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]11
ANHYDROUS DEXTROSEACTIVE MOIETY5SL0G7R0OKLIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]11
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-9598LIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE ANHYDROUS AND DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]18Current NDC, Legacy NDC, 2 package rows20240524_7dff29d9-522d-40eb-a9d9-42377912d640.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737742lidocaine HCl 0.4 % in 250 ML InjectionPSN7dff29d9-522d-40eb-a9d9-42377912d64019
1737744lidocaine HCl 0.4 % in 500 ML InjectionPSN7dff29d9-522d-40eb-a9d9-42377912d64019
1737723lidocaine HCl 0.8 % in 250 ML InjectionPSN7dff29d9-522d-40eb-a9d9-42377912d64019
1737742250 ML lidocaine hydrochloride 4 MG/ML InjectionSCD7dff29d9-522d-40eb-a9d9-42377912d64019
1737723250 ML lidocaine hydrochloride 8 MG/ML InjectionSCD7dff29d9-522d-40eb-a9d9-42377912d64019
1737744500 ML lidocaine hydrochloride 4 MG/ML InjectionSCD7dff29d9-522d-40eb-a9d9-42377912d64019
1737742lidocaine HCl 0.4 % per 250 ML InjectionSY7dff29d9-522d-40eb-a9d9-42377912d64019
1737744lidocaine HCl 0.4 % per 500 ML InjectionSY7dff29d9-522d-40eb-a9d9-42377912d64019
1737723lidocaine HCl 0.8 % per 250 ML InjectionSY7dff29d9-522d-40eb-a9d9-42377912d64019
1737742lidocaine HCl 1 GM per 250 ML InjectionSY7dff29d9-522d-40eb-a9d9-42377912d64019
1737723lidocaine HCl 2 GM per 250 ML InjectionSY7dff29d9-522d-40eb-a9d9-42377912d64019
1737744lidocaine HCl 2 GM per 500 ML InjectionSY7dff29d9-522d-40eb-a9d9-42377912d64019
1737723lidocaine HCl 0.8 % in 250 ML InjectionPSN564e6d42-0d74-40bd-b989-81ff67d7241c4
1737723250 ML lidocaine hydrochloride 8 MG/ML InjectionSCD564e6d42-0d74-40bd-b989-81ff67d7241c4
1737723lidocaine HCl 0.8 % per 250 ML InjectionSY564e6d42-0d74-40bd-b989-81ff67d7241c4
1737723lidocaine HCl 2 GM per 250 ML InjectionSY564e6d42-0d74-40bd-b989-81ff67d7241c4
1737723lidocaine HCl 0.8 % in 250 ML InjectionPSNc75311e3-ca6e-40de-e053-2a95a90a1bda1
1737723250 ML lidocaine hydrochloride 8 MG/ML InjectionSCDc75311e3-ca6e-40de-e053-2a95a90a1bda1
1737723lidocaine HCl 0.8 % per 250 ML InjectionSYc75311e3-ca6e-40de-e053-2a95a90a1bda1
1737723lidocaine HCl 2 GM per 250 ML InjectionSYc75311e3-ca6e-40de-e053-2a95a90a1bda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-9598-200026495982024 CONTAINER in 1 CASE (0264-9598-20) / 250 mL in 1 CONTAINER24 container1992-04-080000-00-00NoNoCurrent