FDA.reportPublic FDA data

NutriLipid I.V. Fat Emulsion

Product NDC
0264-4460
11-digit product format
002644460
Labeler code
0264
Product ID
0264-4460_a2654d29-2a77-4d9b-b4ef-1572a8010d97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Soybean Oil
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
B. Braun Medical Inc.
Application
NDA019531
Marketing category
NDA
Marketing start
2014-06-30
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
NutriLipid I.V. Fat Emulsion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SOYBEAN OIL20 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii241ATL177A
Rxcui200317, 1654849, 1799704, 1799724, 1799886, 1799890, 1799958, 1799959

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
0264-4460-00NutriLipid I.V. Fat Emulsion8 in 1 CASEINJECTION, SOLUTION828
0264-4460-00NutriLipid I.V. Fat Emulsion1 in 1 CARTONINJECTION, SOLUTION128
0264-4460-10NutriLipid I.V. Fat Emulsion12 in 1 CASEINJECTION, SOLUTION1228
0264-4460-10NutriLipid I.V. Fat Emulsion1 in 1 CARTONINJECTION, SOLUTION128
0264-4460-20NutriLipid I.V. Fat Emulsion12 in 1 CASEINJECTION, SOLUTION1228
0264-4460-20NutriLipid I.V. Fat Emulsion1 in 1 CARTONINJECTION, SOLUTION128
0264-4460-30NutriLipid I.V. Fat Emulsion12 in 1 CASEINJECTION, SOLUTION1228
0264-4460-30NutriLipid I.V. Fat Emulsion1 in 1 CARTONINJECTION, SOLUTION128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-4460-00ML - Milliliter0264-446069e466a4-34a7-4309-9a76-f00540f13ce512015-02-02
0264-4460-10ML - Milliliter0264-4460196ac260-9132-43fa-9e7c-54f89d40d4ab12015-02-02
0264-4460-30ML - Milliliter0264-4460d0d7622f-030f-4ffb-a68c-7c13bf54cd3412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOYBEAN OILACTIVE INGREDIENT241ATL177ANUTRILIPID I.V. FAT EMULSION (SOYBEAN OIL) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
SOYBEAN OILACTIVE MOIETY241ATL177ANUTRILIPID I.V. FAT EMULSION (SOYBEAN OIL) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVNUTRILIPID I.V. FAT EMULSION (SOYBEAN OIL) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNUTRILIPID I.V. FAT EMULSION (SOYBEAN OIL) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INUTRILIPID I.V. FAT EMULSION (SOYBEAN OIL) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
SODIUM OLEATEINACTIVE INGREDIENT399SL044HNNUTRILIPID I.V. FAT EMULSION (SOYBEAN OIL) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RNUTRILIPID I.V. FAT EMULSION (SOYBEAN OIL) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0264-4460NUTRILIPID I.V. FAT EMULSION (SOYBEAN OIL) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]24Current NDC, Legacy NDC, 8 package rows20230531_193290b1-a0a1-4054-a22a-de5c9e7a8b73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799886Nutrilipid 20 % in 250 ML InjectionPSN193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799959Nutrilipid 20 % in 350 ML InjectionPSN193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799890Nutrilipid 20 % in 500 ML InjectionPSN193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1654849Nutrilipid 20 % Injectable SuspensionPSN193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799704soybean oil 20 % in 250 ML InjectionPSN193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799958soybean oil 20 % in 350 ML InjectionPSN193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799724soybean oil 20 % in 500 ML InjectionPSN193290b1-a0a1-4054-a22a-de5c9e7a8b7328
200317soybean oil 20 % Injectable SuspensionPSN193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799886250 ML soybean oil 200 MG/ML Injection [Nutrilipid]SBD193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799959350 ML soybean oil 200 MG/ML Injection [Nutrilipid]SBD193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799890500 ML soybean oil 200 MG/ML Injection [Nutrilipid]SBD193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1654849soybean oil 200 MG/ML Injectable Suspension [Nutrilipid]SBD193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799704250 ML soybean oil 200 MG/ML InjectionSCD193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799958350 ML soybean oil 200 MG/ML InjectionSCD193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799724500 ML soybean oil 200 MG/ML InjectionSCD193290b1-a0a1-4054-a22a-de5c9e7a8b7328
200317soybean oil 200 MG/ML Injectable SuspensionSCD193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1654849Nutrilipid 20 % Injectable SuspensionSY193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799886Nutrilipid 20 % per 250 ML InjectionSY193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799959Nutrilipid 20 % per 350 ML InjectionSY193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799890Nutrilipid 20 % per 500 ML InjectionSY193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1654849Nutrilipid 200 MG/ML Injectable SuspensionSY193290b1-a0a1-4054-a22a-de5c9e7a8b7328
200317soybean oil 20 % Injectable SuspensionSY193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799704soybean oil 20 % per 250 ML InjectionSY193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799958soybean oil 20 % per 350 ML InjectionSY193290b1-a0a1-4054-a22a-de5c9e7a8b7328
1799724soybean oil 20 % per 500 ML InjectionSY193290b1-a0a1-4054-a22a-de5c9e7a8b7328

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0264-4460-00002644460008 CARTON in 1 CASE (0264-4460-00) / 1 CONTAINER in 1 CARTON / 1000 mL in 1 CONTAINER8 carton2014-06-300000-00-00NoNoCurrent
0264-4460-100026444601012 CARTON in 1 CASE (0264-4460-10) / 1 CONTAINER in 1 CARTON / 500 mL in 1 CONTAINER12 carton2014-06-300000-00-00NoNoCurrent
0264-4460-200026444602012 in 1 CASEHistorical
0264-4460-300026444603012 CARTON in 1 CASE (0264-4460-30) / 1 CONTAINER in 1 CARTON / 250 mL in 1 CONTAINER12 carton2014-06-300000-00-00NoNoCurrent