FDA.reportPublic FDA data

Lidocaine Hydrochloride and Dextrose

Product NDC
0338-0409
11-digit product format
003380409
Labeler code
0338
Product ID
0338-0409_9e9121a0-25dd-46ba-a2b7-6f71fc3ff9cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA018461
Marketing category
NDA
Marketing start
1981-04-22
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 mg/mL
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
LIDOCAINE HYDROCHLORIDE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
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
0338-0409-02Lidocaine Hydrochloride and Dextrose24 in 1 CARTONINJECTION, SOLUTION2417
0338-0409-02Lidocaine Hydrochloride and Dextrose250 mL in 1 BAGINJECTION, SOLUTION25017
0338-0409-03Lidocaine Hydrochloride and Dextrose18 in 1 CARTONINJECTION, SOLUTION1817
0338-0409-03Lidocaine Hydrochloride and Dextrose500 mL in 1 BAGINJECTION, SOLUTION50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0409-02ML - Milliliter0338-0409efb81e3e-58f8-44f6-9f96-cc072ab1bceb12012-07-24
0338-0409-03ML - Milliliter0338-04096bee9f8e-a4cd-4117-af6b-9bacad79a0fb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GLIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0409LIDOCAINE HYDROCHLORIDE AND DEXTROSE (LIDOCAINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]15Current NDC, Legacy NDC, 4 package rows20240906_f21512ea-c7c3-4766-b976-b2c0b5616bf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737742lidocaine HCl 0.4 % in 250 ML InjectionPSNf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737744lidocaine HCl 0.4 % in 500 ML InjectionPSNf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737723lidocaine HCl 0.8 % in 250 ML InjectionPSNf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737742250 ML lidocaine hydrochloride 4 MG/ML InjectionSCDf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737723250 ML lidocaine hydrochloride 8 MG/ML InjectionSCDf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737744500 ML lidocaine hydrochloride 4 MG/ML InjectionSCDf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737742lidocaine HCl 0.4 % per 250 ML InjectionSYf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737744lidocaine HCl 0.4 % per 500 ML InjectionSYf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737723lidocaine HCl 0.8 % per 250 ML InjectionSYf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737742lidocaine HCl 1 GM per 250 ML InjectionSYf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737723lidocaine HCl 2 GM per 250 ML InjectionSYf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737744lidocaine HCl 2 GM per 500 ML InjectionSYf21512ea-c7c3-4766-b976-b2c0b5616bf017
1737744lidocaine HCl 0.4 % in 500 ML InjectionPSN861ba61a-5835-3b9a-e053-2a91aa0aee5e3
1737744500 ML lidocaine hydrochloride 4 MG/ML InjectionSCD861ba61a-5835-3b9a-e053-2a91aa0aee5e3
1737744lidocaine HCl 0.4 % per 500 ML InjectionSY861ba61a-5835-3b9a-e053-2a91aa0aee5e3
1737744lidocaine HCl 2 GM per 500 ML InjectionSY861ba61a-5835-3b9a-e053-2a91aa0aee5e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0409-020033804090224 BAG in 1 CARTON (0338-0409-02) > 250 mL in 1 BAG24 bag1981-04-220000-00-00NoNoCurrent
0338-0409-030033804090318 BAG in 1 CARTON (0338-0409-03) / 500 mL in 1 BAG18 bag1981-04-220000-00-00NoNoCurrent