Home NDC 63323-820 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 SOYBEAN OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; FISH OIL
Active strength 6; 6; 5; 3 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207648-001 SMOFLIPID 20% FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 N207648-002 SMOFLIPID 20% FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 N207648-003 SMOFLIPID 20% FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 N207648-004 SMOFLIPID 20% FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207648-001 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207648-002 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207648-003 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) EMULSION / INTRAVENOUS RLD, RS 2016-07-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207648-004 SMOFLIPID 20% 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) EMULSION / INTRAVENOUS RLD, RS 2018-08-10 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 144 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Smoflipid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOYBEAN OIL 6 g/100mL MEDIUM-CHAIN TRIGLYCERIDES 6 g/100mL OLIVE OIL 5 g/100mL FISH OIL 3 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-820-00 Smoflipid 10 in 1 CASE INJECTION, EMULSION 10 11 63323-820-01 Smoflipid 100 mL in 1 BAG INJECTION, EMULSION 100 11 63323-820-02 Smoflipid 100 mL in 1 BAG INJECTION, EMULSION 100 11 63323-820-03 Smoflipid 500 mL in 1 BAG INJECTION, EMULSION 500 11 63323-820-04 Smoflipid 250 mL in 1 BAG INJECTION, EMULSION 250 11 63323-820-05 Smoflipid 1000 mL in 1 BAG INJECTION, EMULSION 1000 11 63323-820-10 Smoflipid 6 in 1 CASE INJECTION, EMULSION 6 11 63323-820-12 Smoflipid 20 in 1 CASE INJECTION, EMULSION 20 11 63323-820-50 Smoflipid 12 in 1 CASE INJECTION, EMULSION 12 11 63323-820-74 Smoflipid 10 in 1 CASE INJECTION, EMULSION 10 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-820 SMOFLIPID (SMOFLIPID) INJECTION, EMULSION [FRESENIUS KABI USA, LLC
] 10 Current NDC, Legacy NDC, 10 package rows 20230729_e0e9d917-ff6f-488e-a6a8-0ad59dd17d80.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-820-00 63323082000 10 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01) 10 bag 2016-07-13 0000-00-00 No No Current 63323-820-01 63323082001 100 mL in 1 BAG 100 ml Historical 63323-820-02 63323082002 100 mL in 1 BAG 100 ml Historical 63323-820-03 63323082003 500 mL in 1 BAG 500 ml Historical 63323-820-04 63323082004 250 mL in 1 BAG 250 ml Historical 63323-820-05 63323082005 1000 mL in 1 BAG 1000 ml Historical 63323-820-10 63323082010 6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05) 6 bag 2019-05-27 0000-00-00 No No Current 63323-820-12 63323082012 20 BAG in 1 CASE (63323-820-12) / 100 mL in 1 BAG (63323-820-02) 20 bag 2016-07-13 0000-00-00 No No Current 63323-820-50 63323082050 12 BAG in 1 CASE (63323-820-50) / 500 mL in 1 BAG (63323-820-03) 12 bag 2016-07-13 0000-00-00 No No Current 63323-820-74 63323082074 10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04) 10 bag 2016-07-13 0000-00-00 No No Current