Home NDC 65219-537 Intralipid
Product NDC 65219-537
11-digit product format 652190537
Labeler code 65219
Product ID 65219-537_31a8fa5d-f093-44b0-84a9-919fbd7eccb5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name I.V. Fat Emulsion
Dosage form EMULSION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA019942
Marketing category NDA
Marketing start 2004-04-01
Substance SOYBEAN OIL
Active strength 30 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 42 .
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 N019942-001 INTRALIPID 30% SOYBEAN OIL 30% INJECTABLE / INJECTION RLD, RS 1993-12-30
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 · 42 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 2026-08-18 06:07:40 2026-07 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Intralipid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SOYBEAN OIL 30 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200318 Internal RxNorm lookup 805131 Internal RxNorm lookup
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 65219-537-01 Intralipid 500 mL in 1 BAG EMULSION 500 4 65219-537-50 Intralipid 12 in 1 CASE EMULSION 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-537 INTRALIPID (I.V. FAT EMULSION) EMULSION [FRESENIUS KABI USA, LLC
] 3 Current NDC, 2 package rows 20240427_98460eae-5195-48d2-ab73-00d276879ef6.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-537-01 65219053701 500 mL in 1 BAG 500 ml Historical 65219-537-50 65219053750 12 BAG in 1 CASE (65219-537-50) / 500 mL in 1 BAG (65219-537-01) 12 bag 2023-02-17 No No Current