Home NDC 0338-9540 Clinolipid
Product NDC 0338-9540
11-digit product format 003389540
Labeler code 0338
Product ID 0338-9540_c5a33738-e548-42a3-9085-92b4af29d4f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Olive Oil and Soybean Oil
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application NDA204508
Marketing category NDA
Marketing start 2016-01-01
Substance OLIVE OIL; SOYBEAN OIL
Active strength 16; 4 g/100mL; g/100mL
Pharmacologic classes Lipid Emulsion [EPC], Lipid Emulsion [EPC], Lipids [CS], 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 N204508-001 CLINOLIPID 20% OLIVE OIL; SOYBEAN OIL 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N204508-001 NPP 2027-04-24
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 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD 2013-10-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204508-001 CLINOLIPID 20% 16%(160GM/1000ML);4% (40GM/1000ML) EMULSION / INTRAVENOUS RLD, RS 2013-10-03 f41ea6bd6efb…
Observed Orange Book exclusivity history# 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 Clinolipid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLIVE OIL 16 g/100mL SOYBEAN OIL 4 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6UYK2W1W1E Internal UNII lookup 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 1986373 Internal RxNorm lookup 1986378 Internal RxNorm lookup 1986381 Internal RxNorm lookup 1986382 Internal RxNorm lookup 1986385 Internal RxNorm lookup 1986386 Internal RxNorm lookup 1986388 Internal RxNorm lookup 1986389 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 0338-9540-01 Clinolipid 100 mL in 1 BAG INJECTION, EMULSION 100 23 0338-9540-02 Clinolipid 250 mL in 1 BAG INJECTION, EMULSION 250 23 0338-9540-03 Clinolipid 500 mL in 1 BAG INJECTION, EMULSION 500 23 0338-9540-04 Clinolipid 1000 mL in 1 BAG INJECTION, EMULSION 1000 23 0338-9540-05 Clinolipid 15 in 1 CARTON INJECTION, EMULSION 15 23 0338-9540-06 Clinolipid 10 in 1 CARTON INJECTION, EMULSION 10 23 0338-9540-07 Clinolipid 12 in 1 CARTON INJECTION, EMULSION 12 23 0338-9540-08 Clinolipid 6 in 1 CARTON INJECTION, EMULSION 6 23
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-9540 CLINOLIPID (OLIVE OIL AND SOYBEAN OIL) INJECTION, EMULSION [BAXTER HEALTHCARE CORPORATION] 20 Current NDC, Legacy NDC, 8 package rows 20250410_ae98eb03-c0e7-49d1-b024-77968e3d9d6e.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 0338-9540-01 00338954001 100 mL in 1 BAG 100 ml Historical 0338-9540-02 00338954002 250 mL in 1 BAG 250 ml Historical 0338-9540-03 00338954003 500 mL in 1 BAG 500 ml Historical 0338-9540-04 00338954004 1000 mL in 1 BAG 1000 ml Historical 0338-9540-05 00338954005 15 BAG in 1 CARTON (0338-9540-05) / 100 mL in 1 BAG (0338-9540-01) 15 bag 2016-01-01 0000-00-00 No No Current 0338-9540-06 00338954006 10 BAG in 1 CARTON (0338-9540-06) / 250 mL in 1 BAG (0338-9540-02) 10 bag 2016-01-01 0000-00-00 No No Current 0338-9540-07 00338954007 12 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03) 12 bag 2016-01-01 0000-00-00 No No Current 0338-9540-08 00338954008 6 BAG in 1 CARTON (0338-9540-08) / 1000 mL in 1 BAG (0338-9540-04) 6 bag 2016-01-01 0000-00-00 No No Current