Iodixanol

Product NDC
65219-381
11-digit product format
652190381
Labeler code
65219
Product ID
65219-381_1980ecbd-58c9-4176-af7f-af955bb0ad2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iodixanol
Dosage form
INJECTION, SOLUTION
Route
INTRAVASCULAR
Labeler
FRESENIUS KABI USA, LLC
Application
ANDA214271
Marketing category
ANDA
Marketing start
2022-06-21
Substance
IODIXANOL
Active strength
270 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214271-001IODIXANOLIODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19
A214271-002IODIXANOLIODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214271-001AP
A214271-002AP

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 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-195c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-196a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-191c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214271-001IODIXANOL55%INJECTABLE / INJECTIONAP2022-05-19a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214271-002IODIXANOL65.2%INJECTABLE / INJECTIONAP2022-05-19a72a2bbeb626…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214271-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A214271-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214271-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214271-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214271-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214271-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214271-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214271-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214271-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214271-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214271-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214271-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214271-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214271-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214271-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214271-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214271-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214271-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214271-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214271-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214271-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214271-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214271-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214271-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214271-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214271-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214271-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214271-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214271-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214271-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214271-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214271-002AP15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214271-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214271-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214271-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214271-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214271-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214271-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214271-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214271-002AP1a72a2bbeb626…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2023-12-20 04:57 UTC2023-12A214271-001CGT2023-01-09ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214271-002CGT2023-01-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214271-001CGT2023-01-09a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214271-002CGT2023-01-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214271-001CGT2023-01-099b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214271-002CGT2023-01-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214271-001CGT2023-01-09a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214271-002CGT2023-01-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214271-001CGT2023-01-093f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214271-002CGT2023-01-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A214271-001CGT2023-01-09053a50430f4f…
2023-05-13 08:27 UTC2023-05A214271-002CGT2023-01-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A214271-001CGT2023-01-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A214271-002CGT2023-01-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214271-001CGT2023-01-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214271-002CGT2023-01-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214271-001CGT2023-01-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A214271-002CGT2023-01-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214271-001CGT2023-01-09e64feba35796…
2022-09-29 23:25 UTC2022-09A214271-002CGT2023-01-09e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Iodixanol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IODIXANOL270 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HW8W27HTXXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0fe89ea2-04f7-46c5-9c35-220d8c144a95Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-381-03Iodixanol100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION1005
65219-381-05Iodixanol150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION1505
65219-381-10Iodixanol10 in 1 BOXINJECTION, SOLUTION105
65219-381-50Iodixanol10 in 1 BOXINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-381-03ML - Milliliter65219-381bebe1bd5-02b1-409f-9acf-a2e592d2eda112022-08-04
65219-381-05ML - Milliliter65219-381a721603f-887c-41da-baf6-1b4a28db855312022-08-04
65219-381-10ML - Milliliter65219-3816614216e-a494-4a0a-ad54-7f80b522589d12022-08-04
65219-381-50ML - Milliliter65219-38132d94d88-3c77-4b8c-9cdb-50ecec52379712022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-381IODIXANOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 4 package rows20230803_0fe89ea2-04f7-46c5-9c35-220d8c144a95.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IodixanolIODIXANOLFRESENIUS KABI USA, LLC0fe89ea2-04f7-46c5-9c35-220d8c144a952023-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214271
application number: ANDA214271
ndc (product): 65219-381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-381-0365219038103100 mL in 1 BOTTLE, PLASTIC100 mlHistorical
65219-381-0565219038105150 mL in 1 BOTTLE, PLASTIC150 mlHistorical
65219-381-106521903811010 BOTTLE, PLASTIC in 1 BOX (65219-381-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-381-03) 2022-06-210000-00-00NoNoCurrent
65219-381-506521903815010 BOTTLE, PLASTIC in 1 BOX (65219-381-50) / 150 mL in 1 BOTTLE, PLASTIC (65219-381-05) 2022-06-210000-00-00NoNoCurrent