Home NDC 0264-4460 NutriLipid I.V. Fat Emulsion
Product NDC 0264-4460
11-digit product format 002644460
Labeler code 0264
Product ID 0264-4460_a2654d29-2a77-4d9b-b4ef-1572a8010d97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Soybean Oil
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler B. Braun Medical Inc.
Application NDA019531
Marketing category NDA
Marketing start 2014-06-30
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019531-001 NUTRILIPID 10% SOYBEAN OIL 10% INJECTABLE / INJECTION RLD 1993-05-28 N019531-002 NUTRILIPID 20% SOYBEAN OIL 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019531-002 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD 1993-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD, RS 1993-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD, RS 1993-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION RLD, RS 1993-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019531-001 NUTRILIPID 10% 10% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019531-002 NUTRILIPID 20% 20% INJECTABLE / INJECTION AP RLD, RS 1993-05-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
Additional Listing Data#
Finished product Yes
Brand name base NutriLipid I.V. Fat Emulsion
Listing expiration 2027-12-31 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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200317 Internal RxNorm lookup 1654849 Internal RxNorm lookup 1799704 Internal RxNorm lookup 1799724 Internal RxNorm lookup 1799886 Internal RxNorm lookup 1799890 Internal RxNorm lookup 1799958 Internal RxNorm lookup 1799959 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 0264-4460-00 NutriLipid I.V. Fat Emulsion 8 in 1 CASE INJECTION, SOLUTION 8 28 0264-4460-00 NutriLipid I.V. Fat Emulsion 1 in 1 CARTON INJECTION, SOLUTION 1 28 0264-4460-10 NutriLipid I.V. Fat Emulsion 12 in 1 CASE INJECTION, SOLUTION 12 28 0264-4460-10 NutriLipid I.V. Fat Emulsion 1 in 1 CARTON INJECTION, SOLUTION 1 28 0264-4460-20 NutriLipid I.V. Fat Emulsion 12 in 1 CASE INJECTION, SOLUTION 12 28 0264-4460-20 NutriLipid I.V. Fat Emulsion 1 in 1 CARTON INJECTION, SOLUTION 1 28 0264-4460-30 NutriLipid I.V. Fat Emulsion 12 in 1 CASE INJECTION, SOLUTION 12 28 0264-4460-30 NutriLipid I.V. Fat Emulsion 1 in 1 CARTON INJECTION, SOLUTION 1 28
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-4460 NUTRILIPID I.V. FAT EMULSION (SOYBEAN OIL) INJECTION, SOLUTION [B. BRAUN MEDICAL INC.] 24 Current NDC, Legacy NDC, 8 package rows 20230531_193290b1-a0a1-4054-a22a-de5c9e7a8b73.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 · 1 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 0264-4460-00 00264446000 8 CARTON in 1 CASE (0264-4460-00) / 1 CONTAINER in 1 CARTON / 1000 mL in 1 CONTAINER 8 carton 2014-06-30 0000-00-00 No No Current 0264-4460-10 00264446010 12 CARTON in 1 CASE (0264-4460-10) / 1 CONTAINER in 1 CARTON / 500 mL in 1 CONTAINER 12 carton 2014-06-30 0000-00-00 No No Current 0264-4460-20 00264446020 12 in 1 CASE Historical 0264-4460-30 00264446030 12 CARTON in 1 CASE (0264-4460-30) / 1 CONTAINER in 1 CARTON / 250 mL in 1 CONTAINER 12 carton 2014-06-30 0000-00-00 No No Current