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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207648-001	SMOFLIPID 20%	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)	EMULSION / INTRAVENOUS	RLD, RS	2016-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207648-002	SMOFLIPID 20%	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)	EMULSION / INTRAVENOUS	RLD, RS	2016-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207648-003	SMOFLIPID 20%	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)	EMULSION / INTRAVENOUS	RLD, RS	2016-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207648-004	SMOFLIPID 20%	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2018-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207648-001	SMOFLIPID 20%	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)	EMULSION / INTRAVENOUS	RLD, RS	2016-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207648-002	SMOFLIPID 20%	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)	EMULSION / INTRAVENOUS	RLD, RS	2016-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207648-003	SMOFLIPID 20%	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)	EMULSION / INTRAVENOUS	RLD, RS	2016-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207648-004	SMOFLIPID 20%	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)	EMULSION / INTRAVENOUS	RLD, RS	2018-08-10	`d06236e962d9…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207648-001	NPP	2025-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207648-002	NPP	2025-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207648-003	NPP	2025-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207648-004	NPP	2025-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207648-001	NPP	2025-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207648-002	NPP	2025-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207648-003	NPP	2025-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207648-004	NPP	2025-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207648-001	NPP	2025-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207648-002	NPP	2025-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207648-003	NPP	2025-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207648-004	NPP	2025-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207648-001	NPP	2025-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207648-002	NPP	2025-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207648-003	NPP	2025-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207648-004	NPP	2025-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207648-001	NPP	2025-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207648-002	NPP	2025-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207648-003	NPP	2025-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207648-004	NPP	2025-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207648-001	NPP	2025-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207648-002	NPP	2025-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207648-003	NPP	2025-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207648-004	NPP	2025-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207648-001	NPP	2025-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207648-002	NPP	2025-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207648-003	NPP	2025-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207648-004	NPP	2025-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207648-001	NPP	2025-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207648-002	NPP	2025-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207648-003	NPP	2025-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207648-004	NPP	2025-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207648-001	NPP	2025-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207648-002	NPP	2025-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207648-003	NPP	2025-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207648-004	NPP	2025-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207648-001	NPP	2025-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207648-002	NPP	2025-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207648-003	NPP	2025-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207648-004	NPP	2025-03-22	`79d66fd596c7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Smoflipid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SOYBEAN OIL	3 g/100mL
MEDIUM-CHAIN TRIGLYCERIDES	6 g/100mL
OLIVE OIL	5 g/100mL
FISH OIL	6 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
241ATL177A	Internal UNII lookup
C9H2L21V7U	Internal UNII lookup
6UYK2W1W1E	Internal UNII lookup
XGF7L72M0F	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e0e9d917-ff6f-488e-a6a8-0ad59dd17d80	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cd2aa2bf-3a9a-4fb3-9436-a62d0a299fa7	Product name	1	20230823
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-820-01	ML - Milliliter	63323-820	1c7c6dd8-3a51-4e2e-babb-5ec0ee0fd446	1	2019-09-05
63323-820-03	ML - Milliliter	63323-820	69f529a3-6330-46d1-97df-6bc42173623f	1	2019-09-05
63323-820-04	ML - Milliliter	63323-820	856820e6-848a-4ed7-93ea-9d6d550b386d	1	2019-09-05
63323-820-05	ML - Milliliter	63323-820	3e203373-02ac-4831-9e88-b4008a2c88c2	1	2019-06-19
63323-820-10	ML - Milliliter	63323-820	d5536998-760a-44b1-8e24-7eab7a0eb991	1	2019-06-19

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Smoflipid	SMOFLIPID	Fresenius Kabi USA, LLC	e0e9d917-ff6f-488e-a6a8-0ad59dd17d80	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207648 application number: NDA207648 ndc (product): 63323-820

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XGF7L72M0F	FISH OIL		FISH OIL
C9H2L21V7U	MEDIUM-CHAIN TRIGLYCERIDES	438544-49-1	MEDIUM-CHAIN TRIGLYCERIDES
6UYK2W1W1E	OLIVE OIL	8001-25-0	OLIVE OIL
241ATL177A	SOYBEAN OIL	8001-22-7	SOYBEAN OIL

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Smoflipid - Fresenius Kabi USA, LLC \| Fresenius Kabi AB	Fresenius Kabi USA, LLC \| Fresenius Kabi AB	2025-08-15	HUMAN PRESCRIPTION DRUG LABEL	11