INTRALIPID

Product NDC: 51662-1333
11-digit product format: 516621333
Labeler code: 51662
Product ID: 51662-1333_9f2bf1d8-b0f3-fd8b-e053-2995a90aa3f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: INTRALIPID
Dosage form: EMULSION
Route: INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: NDA018449
Marketing category: NDA
Marketing start: 2018-12-21
Marketing end: 0000-00-00
Substance: SOYBEAN OIL
Active strength: 20 g/100mL
Pharmacologic classes: Lipid Emulsion [EPC],Lipids [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51662-1333		I	Inactivated by FDA		2026-08-11
excluded package	package	51662-1333	51662-1333-1	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51662-1333-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51662-1333-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51662-1333-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51662-1333-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51662-1333-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51662-1333-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51662-1333-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51662-1333-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51662-1333-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51662-1333-1	2025-01-30	C162847	48780-1	9d75b9d1-1ba8-f424-e053-dadaa90a57ce	INTRALIPID 20% 250mL BAG
51662-1333-1	2020-02-07	C162847	48780-1	9d75b9d1-1ba8-f424-e053-dadaa90a57ce	INTRALIPID 20% 250mL BAG
51662-1333-1	2020-01-31	C162847	48780-1	9d75b9d1-1ba8-f424-e053-dadaa90a57ce	INTRALIPID 20% 250mL BAG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51662-1333-1	INTRALIPID	250 mL in 1 BAG	EMULSION	250		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1333	INTRALIPID EMULSION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	3	Legacy NDC, 1 package rows	20200223_7d8d2c75-1766-1215-e053-2a91aa0a3f7d.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
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
1799704	soybean oil 20 % in 250 ML Injection	PSN	7d8d2c75-1766-1215-e053-2a91aa0a3f7d	3
1799704	250 ML soybean oil 200 MG/ML Injection	SCD	7d8d2c75-1766-1215-e053-2a91aa0a3f7d	3
1799704	soybean oil 20 % per 250 ML Injection	SY	7d8d2c75-1766-1215-e053-2a91aa0a3f7d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1333-1	51662133301	250 mL in 1 BAG (51662-1333-1)	250 ml	2018-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INTRALIPID 20% 250mL BAG	HF Acquisition Co LLC, DBA HealthFirst	2020-02-22	HUMAN PRESCRIPTION DRUG LABEL	3