Home NDC 65219-539 Intralipid
Product NDC 65219-539
11-digit product format 652190539
Labeler code 65219
Product ID 65219-539_18cca00d-c31b-4b61-98ed-6e65c82d3789
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name I.V. Fat Emulsion
Dosage form EMULSION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA020248
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 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 N020248-001 INTRALIPID 20% SOYBEAN OIL 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020248-001 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 · 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 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020248-001 INTRALIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1996-08-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200317 Internal RxNorm lookup 805127 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 65219-539-01 Intralipid 1000 mL in 1 BAG EMULSION 1000 3 65219-539-10 Intralipid 6 in 1 CASE EMULSION 6 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-539 INTRALIPID (I.V. FAT EMULSION) EMULSION [FRESENIUS KABI USA, LLC
] 2 Current NDC, 2 package rows 20231019_bdcc364b-77b2-4939-8add-03e5396d46c2.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 · 3 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 65219-539-01 65219053901 1000 mL in 1 BAG 1000 ml Historical 65219-539-10 65219053910 6 BAG in 1 CASE (65219-539-10) / 1000 mL in 1 BAG (65219-539-01) 6 bag 2023-02-17 No No Current