Home NDC 63323-205 Omegaven
Product NDC 63323-205
11-digit product format 633230205
Labeler code 63323
Product ID 63323-205_5cdc585d-835d-4092-850c-12adbcdef9b9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fish oil
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA210589
Marketing category NDA
Marketing start 2018-07-27
Substance FISH OIL
Active strength .1 g/mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210589-001 OMEGAVEN FISH OIL TRIGLYCERIDES 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 N210589-002 OMEGAVEN FISH OIL TRIGLYCERIDES 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27
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 · 86 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 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210589-001 OMEGAVEN 5GM/50ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210589-002 OMEGAVEN 10GM/100ML (0.1GM/ML) EMULSION / INTRAVENOUS RLD, RS 2018-07-27 74a2ff9319b5…
Observed Orange Book patent history# Patent history page 1 of 6 · 232 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-001 9566260 2026-07-30 U-2366 Drug product 2018-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210589-002 9566260 2026-07-30 U-2366 Drug product 2018-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-001 10350186 2024-11-05 U-2585 2019-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-002 10350186 2024-11-05 U-2585 2019-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-001 10350186 2024-11-05 U-2585 2019-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-002 10350186 2024-11-05 U-2585 2019-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-001 10350186 2024-11-05 U-2585 2019-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-001 9566260 2025-07-11 U-2366 Drug product 2018-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-001 9629821 2025-07-11 U-2367 Drug product 2018-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-002 10350186 2024-11-05 U-2585 2019-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-002 9566260 2025-07-11 U-2366 Drug product 2018-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210589-002 9629821 2025-07-11 U-2367 Drug product 2018-08-27 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 126 observed states.
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 Omegaven
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FISH OIL .1 g/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XGF7L72M0F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2053499 Internal RxNorm lookup 2053504 Internal RxNorm lookup 2053513 Internal RxNorm lookup 2053514 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 63323-205-00 Omegaven 10 in 1 CARTON INJECTION, EMULSION 10 6 63323-205-21 Omegaven 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, EMULSION 50 6 63323-205-31 Omegaven 100 mL in 1 VIAL, SINGLE-DOSE INJECTION, EMULSION 100 6 63323-205-50 Omegaven 10 in 1 CARTON INJECTION, EMULSION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-205 OMEGAVEN (FISH OIL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC
] 5 Current NDC, Legacy NDC, 4 package rows 20230728_5d9d0b24-e139-48bf-ab2d-536fb59cf8e0.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 63323-205-00 63323020500 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31) 2018-07-27 0000-00-00 No No Current 63323-205-21 63323020521 50 mL in 1 VIAL, SINGLE-DOSE 50 ml Historical 63323-205-31 63323020531 100 mL in 1 VIAL, SINGLE-DOSE 100 ml Historical 63323-205-50 63323020550 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21) 2018-07-27 0000-00-00 No No Current