Intralipid

Product NDC: 65219-531
11-digit product format: 652190531
Labeler code: 65219
Product ID: 65219-531_9b0d424f-8fab-4d03-9825-beeac68b29db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: I.V. Fat Emulsion
Dosage form: EMULSION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: NDA018449
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

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018449-001	INTRALIPID 20%	SOYBEAN OIL	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N018449-001	AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018449-001	INTRALIPID 20%	20%	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018449-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018449-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018449-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018449-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018449-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018449-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018449-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018449-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018449-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018449-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018449-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018449-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018449-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018449-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018449-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018449-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018449-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018449-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018449-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018449-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018449-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018449-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018449-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018449-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018449-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018449-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018449-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018449-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018449-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018449-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018449-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018449-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018449-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018449-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018449-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018449-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018449-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018449-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018449-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018449-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SOYBEAN OIL	20 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
241ATL177A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1799694	Internal RxNorm lookup
1799696	Internal RxNorm lookup
1799704	Internal RxNorm lookup
1799706	Internal RxNorm lookup
1799724	Internal RxNorm lookup
1799725	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
61e025f1-a38e-4af2-9e18-13ea12977cf5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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	Strength	SPL version
65219-531-01	Intralipid	100 mL in 1 BAG	EMULSION	100		3
65219-531-10	Intralipid	10 in 1 CASE	EMULSION	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-531-01	ML - Milliliter	65219-531	00980f8a-8a87-4618-b48a-f7d72bb0385a	1	2023-07-06
65219-531-10	ML - Milliliter	65219-531	965f2e58-905e-486b-98a5-a2da9708b92a	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-531	INTRALIPID (I.V. FAT EMULSION) EMULSION [FRESENIUS KABI USA, LLC ]	2	Current NDC, 2 package rows	20231024_61e025f1-a38e-4af2-9e18-13ea12977cf5.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Intralipid	I.V. FAT EMULSION	ProPharma Distribution	48c12fbe-c5e8-a1fc-e063-6294a90a15ae	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018449 application number: NDA018449
Intralipid	I.V. FAT EMULSION	Fresenius Kabi USA, LLC	61e025f1-a38e-4af2-9e18-13ea12977cf5	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018449 application number: NDA018449 ndc (product): 65219-531
Intralipid	I.V. FAT EMULSION	ProPharma Distribution	42dffe5a-892b-03ec-e063-6394a90ae50c	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018449 application number: NDA018449
Intralipid	I.V. FAT EMULSION	Baxter Healthcare Corporation	a69c82da-15ba-4d4d-8d7f-871dc3981eb8	2022-07-21	Boxed warning, Adverse reactions	Exact identifier application applno (NDA): 018449 application number: NDA018449

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
241ATL177A	SOYBEAN OIL	8001-22-7	SOYBEAN OIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1799696	Intralipid 20 % in 100 ML Injection	PSN	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799706	Intralipid 20 % in 250 ML Injection	PSN	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799725	Intralipid 20 % in 500 ML Injection	PSN	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799694	soybean oil 20 % in 100 ML Injection	PSN	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799704	soybean oil 20 % in 250 ML Injection	PSN	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799724	soybean oil 20 % in 500 ML Injection	PSN	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799696	100 ML soybean oil 200 MG/ML Injection [Intralipid]	SBD	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799706	250 ML soybean oil 200 MG/ML Injection [Intralipid]	SBD	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799725	500 ML soybean oil 200 MG/ML Injection [Intralipid]	SBD	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799694	100 ML soybean oil 200 MG/ML Injection	SCD	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799704	250 ML soybean oil 200 MG/ML Injection	SCD	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799724	500 ML soybean oil 200 MG/ML Injection	SCD	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799696	Intralipid 20 % per 100 ML Injection	SY	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799706	Intralipid 20 % per 250 ML Injection	SY	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799725	Intralipid 20 % per 500 ML Injection	SY	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799694	soybean oil 20 % per 100 ML Injection	SY	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799704	soybean oil 20 % per 250 ML Injection	SY	61e025f1-a38e-4af2-9e18-13ea12977cf5	3
1799724	soybean oil 20 % per 500 ML Injection	SY	61e025f1-a38e-4af2-9e18-13ea12977cf5	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
65219-531-01	65219053101	100 mL in 1 BAG	100 ml				Historical
65219-531-10	65219053110	10 BAG in 1 CASE (65219-531-10) / 100 mL in 1 BAG (65219-531-01)	10 bag	2023-02-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Intralipid - Fresenius Kabi USA, LLC \| Fresenius Kabi AB Uppsala	Fresenius Kabi USA, LLC \| Fresenius Kabi AB Uppsala	2025-11-19	HUMAN PRESCRIPTION DRUG LABEL	3