Intralipid

Product NDC
65219-537
11-digit product format
652190537
Labeler code
65219
Product ID
65219-537_31a8fa5d-f093-44b0-84a9-919fbd7eccb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
I.V. Fat Emulsion
Dosage form
EMULSION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA019942
Marketing category
NDA
Marketing start
2004-04-01
Substance
SOYBEAN OIL
Active strength
30 g/100mL
Pharmacologic classes
Lipid Emulsion [EPC], Lipids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Intralipid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOYBEAN OIL30 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii241ATL177A
Rxcui200318, 805131

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-537-01Intralipid500 mL in 1 BAGEMULSION5004
65219-537-50Intralipid12 in 1 CASEEMULSION124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-537-01ML - Milliliter65219-5371043f81b-f140-4036-924b-32bfaac58b8212023-07-06
65219-537-50ML - Milliliter65219-537961ecfa1-8863-4b76-857c-c97ed82767ca12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-537INTRALIPID (I.V. FAT EMULSION) EMULSION [FRESENIUS KABI USA, LLC ]3Current NDC, 2 package rows20240427_98460eae-5195-48d2-ab73-00d276879ef6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
805131Intralipid 30 % Injectable SuspensionPSN98460eae-5195-48d2-ab73-00d276879ef64
200318soybean oil 30 % Injectable SuspensionPSN98460eae-5195-48d2-ab73-00d276879ef64
805131soybean oil 300 MG/ML Injectable Suspension [Intralipid]SBD98460eae-5195-48d2-ab73-00d276879ef64
200318soybean oil 300 MG/ML Injectable SuspensionSCD98460eae-5195-48d2-ab73-00d276879ef64
805131Intralipid 30 % Injectable SuspensionSY98460eae-5195-48d2-ab73-00d276879ef64
200318soybean oil 30 % Injectable SuspensionSY98460eae-5195-48d2-ab73-00d276879ef64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-537-0165219053701500 mL in 1 BAG500 mlHistorical
65219-537-506521905375012 BAG in 1 CASE (65219-537-50) / 500 mL in 1 BAG (65219-537-01) 12 bag2023-02-17NoNoCurrent