FDA.reportPublic FDA data

Iodixanol

Product NDC
65219-383
11-digit product format
652190383
Labeler code
65219
Product ID
65219-383_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
320 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
IODIXANOL320 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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
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
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
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
9137811f-f279-8640-5aeb-99fa2145d64dProduct 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
65219-383-02Iodixanol50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION505
65219-383-04Iodixanol100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION1005
65219-383-05Iodixanol10 in 1 BOXINJECTION, SOLUTION105
65219-383-06Iodixanol150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION1505
65219-383-08Iodixanol200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION2005
65219-383-10Iodixanol10 in 1 BOXINJECTION, SOLUTION105
65219-383-50Iodixanol10 in 1 BOXINJECTION, SOLUTION105
65219-383-70Iodixanol10 in 1 BOXINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-383-02ML - Milliliter65219-3839c8f92e1-1d2f-45a3-b106-e667351a3b5912022-08-04
65219-383-04ML - Milliliter65219-38318a8eb9c-3a0e-48f6-923e-b2c69ea83fc612022-08-04
65219-383-05ML - Milliliter65219-38303116f77-4e6e-4156-aa55-494a6947b13312022-08-04
65219-383-06ML - Milliliter65219-383cf036647-b8a2-40df-8d73-8674219ed3b812022-08-04
65219-383-08ML - Milliliter65219-3831720119c-54ab-4428-b510-7259878bd32212022-08-04
65219-383-10ML - Milliliter65219-3837c22f47f-2fea-465a-bbe3-9bfa10568efc12022-08-04
65219-383-50ML - Milliliter65219-38391e05960-b2b9-4287-86cb-6c37c9196f4112022-08-04
65219-383-70ML - Milliliter65219-3831dafed13-5210-487e-8d9e-21ff60c356b112022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-383IODIXANOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 8 package rows20230803_0fe89ea2-04f7-46c5-9c35-220d8c144a95.zip
65219-383BL-C KIT (BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE, LIDOCAINE, IODIXANOL, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1Current NDC, Legacy NDC20250102_798f3bc6-d976-49a6-87a2-fd30c784fc50.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): 65219-383

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578803betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable SuspensionPSN798f3bc6-d976-49a6-87a2-fd30c784fc501
797544isopropyl alcohol 70 % Medicated PadPSN798f3bc6-d976-49a6-87a2-fd30c784fc501
1737566lidocaine HCl 1 % in 5 ML InjectionPSN798f3bc6-d976-49a6-87a2-fd30c784fc501
797730povidone-iodine 10 % Medicated PadPSN798f3bc6-d976-49a6-87a2-fd30c784fc501
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD798f3bc6-d976-49a6-87a2-fd30c784fc501
578803betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable SuspensionSCD798f3bc6-d976-49a6-87a2-fd30c784fc501
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD798f3bc6-d976-49a6-87a2-fd30c784fc501
797730povidone-iodine 100 MG/ML Medicated PadSCD798f3bc6-d976-49a6-87a2-fd30c784fc501
578803betamethasone 3 MG/ML (as betamethasone sodium phosphate) / betamethasone acetate 3 MG/ML Injectable SuspensionSY798f3bc6-d976-49a6-87a2-fd30c784fc501
797544isopropyl alcohol 70 % Medicated PadSY798f3bc6-d976-49a6-87a2-fd30c784fc501
797544isopropyl alcohol 70 % Topical ClothSY798f3bc6-d976-49a6-87a2-fd30c784fc501
797544isopropyl alcohol 70 % Topical SwabSY798f3bc6-d976-49a6-87a2-fd30c784fc501
1737566lidocaine HCl 1 % per 5 ML InjectionSY798f3bc6-d976-49a6-87a2-fd30c784fc501
1737566lidocaine HCl 50 MG per 5 ML InjectionSY798f3bc6-d976-49a6-87a2-fd30c784fc501
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY798f3bc6-d976-49a6-87a2-fd30c784fc501
797730povidone-iodine 10 % Medicated PadSY798f3bc6-d976-49a6-87a2-fd30c784fc501
797730povidone-iodine 10 % Medicated SwabstickSY798f3bc6-d976-49a6-87a2-fd30c784fc501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-383-026521903830250 mL in 1 BOTTLE, PLASTIC50 mlHistorical
65219-383-0465219038304100 mL in 1 BOTTLE, PLASTIC100 mlHistorical
65219-383-056521903830510 BOTTLE, PLASTIC in 1 BOX (65219-383-05) / 50 mL in 1 BOTTLE, PLASTIC (65219-383-02) 2022-06-210000-00-00NoNoCurrent
65219-383-0665219038306150 mL in 1 BOTTLE, PLASTIC150 mlHistorical
65219-383-0865219038308200 mL in 1 BOTTLE, PLASTIC200 mlHistorical
65219-383-106521903831010 BOTTLE, PLASTIC in 1 BOX (65219-383-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-383-04) 2022-06-210000-00-00NoNoCurrent
65219-383-506521903835010 BOTTLE, PLASTIC in 1 BOX (65219-383-50) / 150 mL in 1 BOTTLE, PLASTIC (65219-383-06) 2022-06-210000-00-00NoNoCurrent
65219-383-706521903837010 BOTTLE, PLASTIC in 1 BOX (65219-383-70) / 200 mL in 1 BOTTLE, PLASTIC (65219-383-08) 2022-06-210000-00-00NoNoCurrent