FDA.reportPublic FDA data

Smoflipid

Product NDC
63323-820
11-digit product format
633230820
Labeler code
63323
Product ID
63323-820_9fd35691-76ee-486c-bd65-b47d3df2fef4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Smoflipid
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA207648
Marketing category
NDA
Marketing start
2016-07-13
Substance
FISH OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Active strength
3; 6; 5; 6 g/100mL; g/100mL; 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
Smoflipid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FISH OIL3 g/100mL
MEDIUM-CHAIN TRIGLYCERIDES6 g/100mL
OLIVE OIL5 g/100mL
SOYBEAN OIL6 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXGF7L72M0F, C9H2L21V7U, 6UYK2W1W1E, 241ATL177A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd2aa2bf-3a9a-4fb3-9436-a62d0a299fa7Product name120230823
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
63323-820-00Smoflipid10 in 1 CASEINJECTION, EMULSION1011
63323-820-01Smoflipid100 mL in 1 BAGINJECTION, EMULSION10011
63323-820-02Smoflipid100 mL in 1 BAGINJECTION, EMULSION10011
63323-820-03Smoflipid500 mL in 1 BAGINJECTION, EMULSION50011
63323-820-04Smoflipid250 mL in 1 BAGINJECTION, EMULSION25011
63323-820-05Smoflipid1000 mL in 1 BAGINJECTION, EMULSION100011
63323-820-10Smoflipid6 in 1 CASEINJECTION, EMULSION611
63323-820-12Smoflipid20 in 1 CASEINJECTION, EMULSION2011
63323-820-50Smoflipid12 in 1 CASEINJECTION, EMULSION1211
63323-820-74Smoflipid10 in 1 CASEINJECTION, EMULSION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-820-01ML - Milliliter63323-8201c7c6dd8-3a51-4e2e-babb-5ec0ee0fd44612019-09-05
63323-820-03ML - Milliliter63323-82069f529a3-6330-46d1-97df-6bc42173623f12019-09-05
63323-820-04ML - Milliliter63323-820856820e6-848a-4ed7-93ea-9d6d550b386d12019-09-05
63323-820-05ML - Milliliter63323-8203e203373-02ac-4831-9e88-b4008a2c88c212019-06-19
63323-820-10ML - Milliliter63323-820d5536998-760a-44b1-8e24-7eab7a0eb99112019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-820SMOFLIPID (SMOFLIPID) INJECTION, EMULSION [FRESENIUS KABI USA, LLC ]10Current NDC, Legacy NDC, 10 package rows20230729_e0e9d917-ff6f-488e-a6a8-0ad59dd17d80.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-820-006332308200010 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01) 10 bag2016-07-130000-00-00NoNoCurrent
63323-820-0163323082001100 mL in 1 BAG100 mlHistorical
63323-820-0263323082002100 mL in 1 BAG100 mlHistorical
63323-820-0363323082003500 mL in 1 BAG500 mlHistorical
63323-820-0463323082004250 mL in 1 BAG250 mlHistorical
63323-820-05633230820051000 mL in 1 BAG1000 mlHistorical
63323-820-10633230820106 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05) 6 bag2019-05-270000-00-00NoNoCurrent
63323-820-126332308201220 BAG in 1 CASE (63323-820-12) / 100 mL in 1 BAG (63323-820-02) 20 bag2016-07-130000-00-00NoNoCurrent
63323-820-506332308205012 BAG in 1 CASE (63323-820-50) / 500 mL in 1 BAG (63323-820-03) 12 bag2016-07-130000-00-00NoNoCurrent
63323-820-746332308207410 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04) 10 bag2016-07-130000-00-00NoNoCurrent