Home NDC 0338-0520-13 Intralipid
Product NDC 0338-0520
Requested package NDC 0338-0520-13
11-digit product format 003380520
Labeler code 0338
Product ID 0338-0520_b2f1f6aa-ceed-4246-95df-c3d3c1e0db3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name I. V. Fat Emulsion
Dosage form EMULSION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 N019942-001 INTRALIPID 30% 30% INJECTABLE / INJECTION RLD, RS 1993-12-30 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 0338-0520-13 Intralipid 500 mL in 1 BAG EMULSION 500 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0520 INTRALIPID (I. V. FAT EMULSION) EMULSION [BAXTER HEALTHCARE CORPORATION
] 4 Current NDC, Legacy NDC, 1 package rows 20220820_dd269651-30e8-43f0-880f-484346eaafeb.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 Marketing end Sample Exclude flag Status 0338-0520-13 00338052013 500 mL in 1 BAG (0338-0520-13) 500 ml 2004-04-01 0000-00-00 No No Current