FDA.reportPublic FDA data

Intralipid

Product NDC
0338-0518
11-digit product format
003380518
Labeler code
0338
Product ID
0338-0518_3044bcdc-50b3-437a-ad5e-6871defe1676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
I.V. Fat Emulsion
Dosage form
EMULSION
Route
INTRAVENOUS
Labeler
Baxter Healthcare CORP
Application
NDA017643
Marketing category
NDA
Marketing start
2014-12-12
Substance
SOYBEAN OIL
Active strength
10 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 OIL10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii241ATL177A
Rxcui1859372, 1859373, 1859374, 1859375, 1859368, 1859370

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
0338-0518-12Intralipid250 mL in 1 BAGEMULSION2504
0338-0518-13Intralipid500 mL in 1 BAGEMULSION5004
0338-0518-58Intralipid100 mL in 1 BAGEMULSION1004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOYBEAN OILACTIVE INGREDIENT241ATL177AINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORP]1
SOYBEAN OILACTIVE MOIETY241ATL177AINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORP]1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0518INTRALIPID (I.V. FAT EMULSION) EMULSION [BAXTER HEALTHCARE CORP ]4Current NDC, Legacy NDC, 3 package rows20220730_069460a5-3e9a-428f-b2dc-3405690f4fd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1859370Intralipid 10 % in 100 ML InjectionPSN069460a5-3e9a-428f-b2dc-3405690f4fd74
1859373Intralipid 10 % in 250 ML InjectionPSN069460a5-3e9a-428f-b2dc-3405690f4fd74
1859375Intralipid 10 % in 500 ML InjectionPSN069460a5-3e9a-428f-b2dc-3405690f4fd74
1859368soybean oil 10 % in 100 ML InjectionPSN069460a5-3e9a-428f-b2dc-3405690f4fd74
1859372soybean oil 10 % in 250 ML InjectionPSN069460a5-3e9a-428f-b2dc-3405690f4fd74
1859374soybean oil 10 % in 500 ML InjectionPSN069460a5-3e9a-428f-b2dc-3405690f4fd74
1859370100 ML soybean oil 100 MG/ML Injection [Intralipid]SBD069460a5-3e9a-428f-b2dc-3405690f4fd74
1859373250 ML soybean oil 100 MG/ML Injection [Intralipid]SBD069460a5-3e9a-428f-b2dc-3405690f4fd74
1859375500 ML soybean oil 100 MG/ML Injection [Intralipid]SBD069460a5-3e9a-428f-b2dc-3405690f4fd74
1859368100 ML soybean oil 100 MG/ML InjectionSCD069460a5-3e9a-428f-b2dc-3405690f4fd74
1859372250 ML soybean oil 100 MG/ML InjectionSCD069460a5-3e9a-428f-b2dc-3405690f4fd74
1859374500 ML soybean oil 100 MG/ML InjectionSCD069460a5-3e9a-428f-b2dc-3405690f4fd74
1859370100 ML Intralipid 100 MG/ML InjectionSY069460a5-3e9a-428f-b2dc-3405690f4fd74
1859373250 ML Intralipid 100 MG/ML InjectionSY069460a5-3e9a-428f-b2dc-3405690f4fd74
1859375500 ML Intralipid 100 MG/ML InjectionSY069460a5-3e9a-428f-b2dc-3405690f4fd74
1859370Intralipid 10 % per 100 ML InjectionSY069460a5-3e9a-428f-b2dc-3405690f4fd74
1859373Intralipid 10 % per 250 ML InjectionSY069460a5-3e9a-428f-b2dc-3405690f4fd74
1859375Intralipid 10 % per 500 ML InjectionSY069460a5-3e9a-428f-b2dc-3405690f4fd74
1859368soybean oil 10 % per 100 ML InjectionSY069460a5-3e9a-428f-b2dc-3405690f4fd74
1859372soybean oil 10 % per 250 ML InjectionSY069460a5-3e9a-428f-b2dc-3405690f4fd74
1859374soybean oil 10 % per 500 ML InjectionSY069460a5-3e9a-428f-b2dc-3405690f4fd74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0518-1200338051812250 mL in 1 BAG (0338-0518-12) 250 ml2014-12-120000-00-00NoNoCurrent
0338-0518-1300338051813500 mL in 1 BAG (0338-0518-13) 500 ml2014-12-120000-00-00NoNoCurrent
0338-0518-5800338051858100 mL in 1 BAG (0338-0518-58) 100 ml2014-12-120000-00-00NoNoCurrent