FDA.reportPublic FDA data

Intralipid

Product NDC
65219-533
11-digit product format
652190533
Labeler code
65219
Product ID
65219-533_9b0d424f-8fab-4d03-9825-beeac68b29db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
I.V. Fat Emulsion
Dosage form
EMULSION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA018449
Marketing category
NDA
Marketing start
2004-04-01
Substance
SOYBEAN OIL
Active strength
20 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 OIL20 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii241ATL177A
Rxcui1799694, 1799696, 1799704, 1799706, 1799724, 1799725

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
65219-533-01Intralipid250 mL in 1 BAGEMULSION2503
65219-533-25Intralipid10 in 1 CASEEMULSION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-533-01ML - Milliliter65219-533d10c4338-8313-4906-9375-57c0849a20e712023-07-06
65219-533-25ML - Milliliter65219-5339ea780d4-4e65-4479-9fc0-20d831e0d9e412023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-533INTRALIPID (I.V. FAT EMULSION) EMULSION [FRESENIUS KABI USA, LLC ]2Current NDC, 2 package rows20231024_61e025f1-a38e-4af2-9e18-13ea12977cf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799696Intralipid 20 % in 100 ML InjectionPSN61e025f1-a38e-4af2-9e18-13ea12977cf53
1799706Intralipid 20 % in 250 ML InjectionPSN61e025f1-a38e-4af2-9e18-13ea12977cf53
1799725Intralipid 20 % in 500 ML InjectionPSN61e025f1-a38e-4af2-9e18-13ea12977cf53
1799694soybean oil 20 % in 100 ML InjectionPSN61e025f1-a38e-4af2-9e18-13ea12977cf53
1799704soybean oil 20 % in 250 ML InjectionPSN61e025f1-a38e-4af2-9e18-13ea12977cf53
1799724soybean oil 20 % in 500 ML InjectionPSN61e025f1-a38e-4af2-9e18-13ea12977cf53
1799696100 ML soybean oil 200 MG/ML Injection [Intralipid]SBD61e025f1-a38e-4af2-9e18-13ea12977cf53
1799706250 ML soybean oil 200 MG/ML Injection [Intralipid]SBD61e025f1-a38e-4af2-9e18-13ea12977cf53
1799725500 ML soybean oil 200 MG/ML Injection [Intralipid]SBD61e025f1-a38e-4af2-9e18-13ea12977cf53
1799694100 ML soybean oil 200 MG/ML InjectionSCD61e025f1-a38e-4af2-9e18-13ea12977cf53
1799704250 ML soybean oil 200 MG/ML InjectionSCD61e025f1-a38e-4af2-9e18-13ea12977cf53
1799724500 ML soybean oil 200 MG/ML InjectionSCD61e025f1-a38e-4af2-9e18-13ea12977cf53
1799696Intralipid 20 % per 100 ML InjectionSY61e025f1-a38e-4af2-9e18-13ea12977cf53
1799706Intralipid 20 % per 250 ML InjectionSY61e025f1-a38e-4af2-9e18-13ea12977cf53
1799725Intralipid 20 % per 500 ML InjectionSY61e025f1-a38e-4af2-9e18-13ea12977cf53
1799694soybean oil 20 % per 100 ML InjectionSY61e025f1-a38e-4af2-9e18-13ea12977cf53
1799704soybean oil 20 % per 250 ML InjectionSY61e025f1-a38e-4af2-9e18-13ea12977cf53
1799724soybean oil 20 % per 500 ML InjectionSY61e025f1-a38e-4af2-9e18-13ea12977cf53
1799706Intralipid 20 % in 250 ML InjectionPSN48c12fbe-c5e8-a1fc-e063-6294a90a15ae1
1799704soybean oil 20 % in 250 ML InjectionPSN48c12fbe-c5e8-a1fc-e063-6294a90a15ae1
1799706250 ML soybean oil 200 MG/ML Injection [Intralipid]SBD48c12fbe-c5e8-a1fc-e063-6294a90a15ae1
1799704250 ML soybean oil 200 MG/ML InjectionSCD48c12fbe-c5e8-a1fc-e063-6294a90a15ae1
1799706Intralipid 20 % per 250 ML InjectionSY48c12fbe-c5e8-a1fc-e063-6294a90a15ae1
1799704soybean oil 20 % per 250 ML InjectionSY48c12fbe-c5e8-a1fc-e063-6294a90a15ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-533-0165219053301250 mL in 1 BAG250 mlHistorical
65219-533-256521905332510 BAG in 1 CASE (65219-533-25) / 250 mL in 1 BAG (65219-533-01) 10 bag2023-02-17NoNoCurrent