FDA.reportPublic FDA data

Clinolipid

Product NDC
0338-9540
11-digit product format
003389540
Labeler code
0338
Product ID
0338-9540_c5a33738-e548-42a3-9085-92b4af29d4f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olive Oil and Soybean Oil
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA204508
Marketing category
NDA
Marketing start
2016-01-01
Substance
OLIVE OIL; SOYBEAN OIL
Active strength
16; 4 g/100mL; g/100mL
Pharmacologic classes
Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], 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
Clinolipid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLIVE OIL16 g/100mL
SOYBEAN OIL4 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6UYK2W1W1E, 241ATL177A
Rxcui1986373, 1986378, 1986381, 1986382, 1986385, 1986386, 1986388, 1986389

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
0338-9540-01Clinolipid100 mL in 1 BAGINJECTION, EMULSION10023
0338-9540-02Clinolipid250 mL in 1 BAGINJECTION, EMULSION25023
0338-9540-03Clinolipid500 mL in 1 BAGINJECTION, EMULSION50023
0338-9540-04Clinolipid1000 mL in 1 BAGINJECTION, EMULSION100023
0338-9540-05Clinolipid15 in 1 CARTONINJECTION, EMULSION1523
0338-9540-06Clinolipid10 in 1 CARTONINJECTION, EMULSION1023
0338-9540-07Clinolipid12 in 1 CARTONINJECTION, EMULSION1223
0338-9540-08Clinolipid6 in 1 CARTONINJECTION, EMULSION623

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9540-01ML - Milliliter0338-95407ed264c3-e2fc-4169-b66f-9c0136b386d412019-07-02
0338-9540-02ML - Milliliter0338-9540b0b2f114-43ed-4b3c-858a-fec30ab85a4812019-07-02
0338-9540-03ML - Milliliter0338-954090126cb2-8c21-4136-9e98-20694d29b4e112019-07-02
0338-9540-04ML - Milliliter0338-9540a57fe463-722e-4640-b04d-e1df0e6a504412019-07-02
0338-9540-05ML - Milliliter0338-95407672dc61-4f3a-43f1-8e52-18a985efdc9a12019-07-02
0338-9540-06ML - Milliliter0338-95409b40769c-3de8-4068-8003-e0bc77f481da12019-07-02
0338-9540-07ML - Milliliter0338-95405d9c6ecc-5f82-44af-979c-1cbf6ccd84ff12019-07-02
0338-9540-08ML - Milliliter0338-9540c02b0c24-3a15-4093-83f0-74a9953ec26212019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLIVE OILACTIVE INGREDIENT6UYK2W1W1ECLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
SOYBEAN OILACTIVE INGREDIENT241ATL177ACLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
OLIVE OILACTIVE MOIETY6UYK2W1W1ECLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
SOYBEAN OILACTIVE MOIETY241ATL177ACLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVCLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1
SODIUM OLEATEINACTIVE INGREDIENT399SL044HNCLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9540CLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION]20Current NDC, Legacy NDC, 8 package rows20250410_ae98eb03-c0e7-49d1-b024-77968e3d9d6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1986389Clinolipid 20 % in 100 mL InjectionPSNae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986378Clinolipid 20 % in 1000 mL InjectionPSNae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986386Clinolipid 20 % in 250 mL InjectionPSNae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986382Clinolipid 20 % in 500 mL InjectionPSNae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986388olive oil 16 % / soybean oil 4 % in 100 mL InjectionPSNae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986373olive oil 16 % / soybean oil 4 % in 1000 mL InjectionPSNae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986385olive oil 16 % / soybean oil 4 % in 250 mL InjectionPSNae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986381olive oil 16 % / soybean oil 4 % in 500 mL InjectionPSNae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986389100 ML olive oil 160 MG/ML / soybean oil 40 MG/ML Injection [Clinolipid]SBDae98eb03-c0e7-49d1-b024-77968e3d9d6e23
19863781000 ML olive oil 160 MG/ML / soybean oil 40 MG/ML Injection [Clinolipid]SBDae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986386250 ML olive oil 160 MG/ML / soybean oil 40 MG/ML Injection [Clinolipid]SBDae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986382500 ML olive oil 160 MG/ML / soybean oil 40 MG/ML Injection [Clinolipid]SBDae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986388100 ML olive oil 160 MG/ML / soybean oil 40 MG/ML InjectionSCDae98eb03-c0e7-49d1-b024-77968e3d9d6e23
19863731000 ML olive oil 160 MG/ML / soybean oil 40 MG/ML InjectionSCDae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986385250 ML olive oil 160 MG/ML / soybean oil 40 MG/ML InjectionSCDae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986381500 ML olive oil 160 MG/ML / soybean oil 40 MG/ML InjectionSCDae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986389Clinolipid 20 % per 100 ML InjectionSYae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986378Clinolipid 20 % per 1000 ML InjectionSYae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986386Clinolipid 20 % per 250 ML InjectionSYae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986382Clinolipid 20 % per 500 ML InjectionSYae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986388olive oil 16 % / soybean oil 4 % per 100 ML InjectionSYae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986373olive oil 16 % / soybean oil 4 % per 1000 ML InjectionSYae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986385olive oil 16 % / soybean oil 4 % per 250 ML InjectionSYae98eb03-c0e7-49d1-b024-77968e3d9d6e23
1986381olive oil 16 % / soybean oil 4 % per 500 ML InjectionSYae98eb03-c0e7-49d1-b024-77968e3d9d6e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-9540-0100338954001100 mL in 1 BAG100 mlHistorical
0338-9540-0200338954002250 mL in 1 BAG250 mlHistorical
0338-9540-0300338954003500 mL in 1 BAG500 mlHistorical
0338-9540-04003389540041000 mL in 1 BAG1000 mlHistorical
0338-9540-050033895400515 BAG in 1 CARTON (0338-9540-05) / 100 mL in 1 BAG (0338-9540-01) 15 bag2016-01-010000-00-00NoNoCurrent
0338-9540-060033895400610 BAG in 1 CARTON (0338-9540-06) / 250 mL in 1 BAG (0338-9540-02) 10 bag2016-01-010000-00-00NoNoCurrent
0338-9540-070033895400712 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03) 12 bag2016-01-010000-00-00NoNoCurrent
0338-9540-08003389540086 BAG in 1 CARTON (0338-9540-08) / 1000 mL in 1 BAG (0338-9540-04) 6 bag2016-01-010000-00-00NoNoCurrent