FDA.reportPublic FDA data

LMD in Dextrose

Product NDC
0409-7418
11-digit product format
004097418
Labeler code
0409
Product ID
0409-7418_7dc616ab-1417-4950-9e1f-2deb01b83c1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTRAN 40
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
BA720563
Marketing category
ANDA
Marketing start
2006-02-14
Substance
DEXTRAN 40
Active strength
10 g/100mL
Pharmacologic classes
Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LMD in Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTRAN 4010 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3R6ZDH4DUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
244250Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c273512-84e2-2cea-b201-12345a6bd1feAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0409-7418-032023-02-14C16284748780-1f386c649-ef23-0266-e053-dadaa90a7c1a10% LMD in 5% Dextrose Injection Rx only (Dextran 40 in Dextrose Injection, USP)
0409-7418-032023-01-30C16284748780-1f386c649-ef23-0266-e053-dadaa90a7c1a10% LMD in 5% Dextrose Injection Rx only (Dextran 40 in Dextrose Injection, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-7418-03LMD in Dextrose12 in 1 CASEINJECTION, SOLUTION1226
0409-7418-03LMD in Dextrose1 in 1 POUCHINJECTION, SOLUTION126
0409-7418-13LMD in Dextrose500 mL in 1 BAGINJECTION, SOLUTION50026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7418-03ML - Milliliter0409-74185db31079-617a-4eae-86e0-c3e9800fcd2b12012-07-24
0409-7418-13ML - Milliliter0409-741870946347-60a9-4588-bb2e-4fb725802f1012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTRAN 40ACTIVE INGREDIENTK3R6ZDH4DULMD IN DEXTROSE (DEXTRAN 40) INJECTION, SOLUTION LMD IN SODIUM CHLORIDE (DEXTRAN 40) INJECTION, SOLUTION [HOSPIRA, INC.]13
DEXTRAN 40ACTIVE MOIETYK3R6ZDH4DULMD IN DEXTROSE (DEXTRAN 40) INJECTION, SOLUTION LMD IN SODIUM CHLORIDE (DEXTRAN 40) INJECTION, SOLUTION [HOSPIRA, INC.]13
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GLMD IN DEXTROSE (DEXTRAN 40) INJECTION, SOLUTION LMD IN SODIUM CHLORIDE (DEXTRAN 40) INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLMD IN DEXTROSE (DEXTRAN 40) INJECTION, SOLUTION LMD IN SODIUM CHLORIDE (DEXTRAN 40) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLMD IN DEXTROSE (DEXTRAN 40) INJECTION, SOLUTION LMD IN SODIUM CHLORIDE (DEXTRAN 40) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILMD IN DEXTROSE (DEXTRAN 40) INJECTION, SOLUTION LMD IN SODIUM CHLORIDE (DEXTRAN 40) INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RLMD IN DEXTROSE (DEXTRAN 40) INJECTION, SOLUTION LMD IN SODIUM CHLORIDE (DEXTRAN 40) INJECTION, SOLUTION [HOSPIRA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-7418LMD IN DEXTROSE (DEXTRAN 40) INJECTION, SOLUTION LMD IN SODIUM CHLORIDE (DEXTRAN 40) INJECTION, SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 3 package rows20230215_3c273512-84e2-2cea-b201-12345a6bd1fe.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LMD in DextroseDEXTRAN 40Hospira, Inc.3c273512-84e2-2cea-b201-12345a6bd1fe2026-05-22Warnings, Adverse reactionsExact identifier
application number: BA720563
ndc (product): 0409-7418

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244250dextran 40 10 % in 500 ML InjectionPSN3c273512-84e2-2cea-b201-12345a6bd1fe26
244250500 ML dextran 40 100 MG/ML InjectionSCD3c273512-84e2-2cea-b201-12345a6bd1fe26
244250dextran 40 10 % in 0.9 % sodium chloride per 500 ML InjectionSY3c273512-84e2-2cea-b201-12345a6bd1fe26
244250dextran 40 10 % in 5 % dextrose per 500 ML InjectionSY3c273512-84e2-2cea-b201-12345a6bd1fe26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-7418-030040974180312 POUCH in 1 CASE (0409-7418-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG (0409-7418-13) 12 pouch2006-02-140000-00-00NoNoCurrent
0409-7418-1300409741813500 mL in 1 BAG500 mlHistorical