FDA.reportPublic FDA data

Intralipid

Product NDC
0338-0519
11-digit product format
003380519
Labeler code
0338
Product ID
0338-0519_75a235ef-1390-4ba5-abe5-27744d698537
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
I.V. Fat Emulsion
Dosage form
EMULSION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA020248
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
Rxcui200317, 805127, 1799694, 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
0338-0519-04Intralipid1000 mL in 1 BAGEMULSION10005
0338-0519-09Intralipid250 mL in 1 BAGEMULSION2504
0338-0519-13Intralipid500 mL in 1 BAGEMULSION5004
0338-0519-14Intralipid1000 mL in 1 BAGEMULSION10004
0338-0519-58Intralipid100 mL in 1 BAGEMULSION1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0519-02ML - Milliliter0338-0519d5fe91af-2ffd-4a90-9af3-c9ec16f801d412012-07-24
0338-0519-03ML - Milliliter0338-05193b8c0a3a-097e-4496-a6da-36feb0cd6d1b12012-07-24
0338-0519-04ML - Milliliter0338-05191105c3d4-4f75-4c24-bdfb-c28bf514f53912013-02-11
0338-0519-09ML - Milliliter0338-051981b15b2d-d826-456c-b342-9d28958b1b9312015-09-10
0338-0519-13ML - Milliliter0338-051998b3cd70-ec1a-4ee7-bd5f-f580717fc2b112015-09-10
0338-0519-14ML - Milliliter0338-0519657816b3-f8e7-43ad-9af3-c3968e0081a512015-09-10
0338-0519-48ML - Milliliter0338-0519299a2c06-c949-42c4-b319-46a0fffe5a8812012-07-24
0338-0519-58ML - Milliliter0338-0519e843bc9e-3535-4047-8018-7a02dd95a32b12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOYBEAN OILACTIVE INGREDIENT241ATL177AINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORPORATION]4
SOYBEAN OILACTIVE MOIETY241ATL177AINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORPORATION]4
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORPORATION]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORPORATION]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORPORATION]4
SOYBEAN OILACTIVE INGREDIENT241ATL177AINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORP]1
SOYBEAN OILACTIVE INGREDIENT241ATL177AINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORP]1
SOYBEAN OILACTIVE MOIETY241ATL177AINTRALIPID (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
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINTRALIPID (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
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IINTRALIPID (SOYBEAN OIL) EMULSION [BAXTER HEALTHCARE CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0519INTRALIPID (I.V. FAT EMULSION) EMULSION [BAXTER HEALTHCARE CORPORATION]5Current NDC, Legacy NDC, 1 package rows20190330_cbd3396e-6b85-41bf-82d2-940beba86686.zip
0338-0519INTRALIPID (I.V. FAT EMULSION) EMULSION [BAXTER HEALTHCARE CORPORATION ]4Current NDC, Legacy NDC, 3 package rows20220812_a69c82da-15ba-4d4d-8d7f-871dc3981eb8.zip
0338-0519INTRALIPID (I.V. FAT EMULSION) EMULSION [BAXTER HEALTHCARE CORPORATION ]4Current NDC, Legacy NDC, 1 package rows20220812_55609586-f0b4-42e6-8dd9-cd090afb5dca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799696Intralipid 20 % in 100 ML InjectionPSNcbd3396e-6b85-41bf-82d2-940beba866865
1799706Intralipid 20 % in 250 ML InjectionPSNcbd3396e-6b85-41bf-82d2-940beba866865
1799725Intralipid 20 % in 500 ML InjectionPSNcbd3396e-6b85-41bf-82d2-940beba866865
805127Intralipid 20 % Injectable SuspensionPSNcbd3396e-6b85-41bf-82d2-940beba866865
1799694soybean oil 20 % in 100 ML InjectionPSNcbd3396e-6b85-41bf-82d2-940beba866865
1799704soybean oil 20 % in 250 ML InjectionPSNcbd3396e-6b85-41bf-82d2-940beba866865
1799724soybean oil 20 % in 500 ML InjectionPSNcbd3396e-6b85-41bf-82d2-940beba866865
200317soybean oil 20 % Injectable SuspensionPSNcbd3396e-6b85-41bf-82d2-940beba866865
1799696100 ML soybean oil 200 MG/ML Injection [Intralipid]SBDcbd3396e-6b85-41bf-82d2-940beba866865
1799706250 ML soybean oil 200 MG/ML Injection [Intralipid]SBDcbd3396e-6b85-41bf-82d2-940beba866865
1799725500 ML soybean oil 200 MG/ML Injection [Intralipid]SBDcbd3396e-6b85-41bf-82d2-940beba866865
805127soybean oil 200 MG/ML Injectable Suspension [Intralipid]SBDcbd3396e-6b85-41bf-82d2-940beba866865
1799694100 ML soybean oil 200 MG/ML InjectionSCDcbd3396e-6b85-41bf-82d2-940beba866865
1799704250 ML soybean oil 200 MG/ML InjectionSCDcbd3396e-6b85-41bf-82d2-940beba866865
1799724500 ML soybean oil 200 MG/ML InjectionSCDcbd3396e-6b85-41bf-82d2-940beba866865
200317soybean oil 200 MG/ML Injectable SuspensionSCDcbd3396e-6b85-41bf-82d2-940beba866865
805127Intralipid 20 % Injectable SuspensionSYcbd3396e-6b85-41bf-82d2-940beba866865
1799696Intralipid 20 % per 100 ML InjectionSYcbd3396e-6b85-41bf-82d2-940beba866865
1799706Intralipid 20 % per 250 ML InjectionSYcbd3396e-6b85-41bf-82d2-940beba866865
1799725Intralipid 20 % per 500 ML InjectionSYcbd3396e-6b85-41bf-82d2-940beba866865
805127Intralipid 200 MG/ML Injectable SuspensionSYcbd3396e-6b85-41bf-82d2-940beba866865
200317soybean oil 20 % Injectable SuspensionSYcbd3396e-6b85-41bf-82d2-940beba866865
1799694soybean oil 20 % per 100 ML InjectionSYcbd3396e-6b85-41bf-82d2-940beba866865
1799704soybean oil 20 % per 250 ML InjectionSYcbd3396e-6b85-41bf-82d2-940beba866865
1799724soybean oil 20 % per 500 ML InjectionSYcbd3396e-6b85-41bf-82d2-940beba866865
1799696Intralipid 20 % in 100 ML InjectionPSN55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799696Intralipid 20 % in 100 ML InjectionPSNa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799706Intralipid 20 % in 250 ML InjectionPSN55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799706Intralipid 20 % in 250 ML InjectionPSNa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799725Intralipid 20 % in 500 ML InjectionPSN55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799725Intralipid 20 % in 500 ML InjectionPSNa69c82da-15ba-4d4d-8d7f-871dc3981eb84
805127Intralipid 20 % Injectable SuspensionPSN55609586-f0b4-42e6-8dd9-cd090afb5dca4
805127Intralipid 20 % Injectable SuspensionPSNa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799694soybean oil 20 % in 100 ML InjectionPSN55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799694soybean oil 20 % in 100 ML InjectionPSNa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799704soybean oil 20 % in 250 ML InjectionPSN55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799704soybean oil 20 % in 250 ML InjectionPSNa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799724soybean oil 20 % in 500 ML InjectionPSNa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799724soybean oil 20 % in 500 ML InjectionPSN55609586-f0b4-42e6-8dd9-cd090afb5dca4
200317soybean oil 20 % Injectable SuspensionPSN55609586-f0b4-42e6-8dd9-cd090afb5dca4
200317soybean oil 20 % Injectable SuspensionPSNa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799696100 ML soybean oil 200 MG/ML Injection [Intralipid]SBD55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799696100 ML soybean oil 200 MG/ML Injection [Intralipid]SBDa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799706250 ML soybean oil 200 MG/ML Injection [Intralipid]SBDa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799706250 ML soybean oil 200 MG/ML Injection [Intralipid]SBD55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799725500 ML soybean oil 200 MG/ML Injection [Intralipid]SBDa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799725500 ML soybean oil 200 MG/ML Injection [Intralipid]SBD55609586-f0b4-42e6-8dd9-cd090afb5dca4
805127soybean oil 200 MG/ML Injectable Suspension [Intralipid]SBDa69c82da-15ba-4d4d-8d7f-871dc3981eb84
805127soybean oil 200 MG/ML Injectable Suspension [Intralipid]SBD55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799694100 ML soybean oil 200 MG/ML InjectionSCDa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799694100 ML soybean oil 200 MG/ML InjectionSCD55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799704250 ML soybean oil 200 MG/ML InjectionSCDa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799704250 ML soybean oil 200 MG/ML InjectionSCD55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799724500 ML soybean oil 200 MG/ML InjectionSCDa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799724500 ML soybean oil 200 MG/ML InjectionSCD55609586-f0b4-42e6-8dd9-cd090afb5dca4
200317soybean oil 200 MG/ML Injectable SuspensionSCDa69c82da-15ba-4d4d-8d7f-871dc3981eb84
200317soybean oil 200 MG/ML Injectable SuspensionSCD55609586-f0b4-42e6-8dd9-cd090afb5dca4
805127Intralipid 20 % Injectable SuspensionSY55609586-f0b4-42e6-8dd9-cd090afb5dca4
805127Intralipid 20 % Injectable SuspensionSYa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799696Intralipid 20 % per 100 ML InjectionSY55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799696Intralipid 20 % per 100 ML InjectionSYa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799706Intralipid 20 % per 250 ML InjectionSYa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799706Intralipid 20 % per 250 ML InjectionSY55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799725Intralipid 20 % per 500 ML InjectionSYa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799725Intralipid 20 % per 500 ML InjectionSY55609586-f0b4-42e6-8dd9-cd090afb5dca4
805127Intralipid 200 MG/ML Injectable SuspensionSYa69c82da-15ba-4d4d-8d7f-871dc3981eb84
805127Intralipid 200 MG/ML Injectable SuspensionSY55609586-f0b4-42e6-8dd9-cd090afb5dca4
200317soybean oil 20 % Injectable SuspensionSYa69c82da-15ba-4d4d-8d7f-871dc3981eb84
200317soybean oil 20 % Injectable SuspensionSY55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799694soybean oil 20 % per 100 ML InjectionSYa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799694soybean oil 20 % per 100 ML InjectionSY55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799704soybean oil 20 % per 250 ML InjectionSYa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799704soybean oil 20 % per 250 ML InjectionSY55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799724soybean oil 20 % per 500 ML InjectionSYa69c82da-15ba-4d4d-8d7f-871dc3981eb84
1799724soybean oil 20 % per 500 ML InjectionSY55609586-f0b4-42e6-8dd9-cd090afb5dca4
1799704soybean oil 20 % in 250 ML InjectionPSN7d8d2c75-1766-1215-e053-2a91aa0a3f7d3
1799704250 ML soybean oil 200 MG/ML InjectionSCD7d8d2c75-1766-1215-e053-2a91aa0a3f7d3
1799704soybean oil 20 % per 250 ML InjectionSY7d8d2c75-1766-1215-e053-2a91aa0a3f7d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0519-04003380519041000 mL in 1 BAG (0338-0519-04) 1000 ml2004-04-010000-00-00NoNoCurrent
0338-0519-0900338051909250 mL in 1 BAG (0338-0519-09) 250 ml2004-04-010000-00-00NoNoCurrent
0338-0519-1300338051913500 mL in 1 BAG (0338-0519-13) 500 ml2004-04-010000-00-00NoNoCurrent
0338-0519-14003380519141000 mL in 1 BAG (0338-0519-14) 1000 ml2004-04-010000-00-00NoNoCurrent
0338-0519-5800338051958100 mL in 1 BAG (0338-0519-58) 100 ml2004-04-010000-00-00NoNoCurrent