OMNIPAQUE

Product NDC
0407-1413
11-digit product format
004071413
Labeler code
0407
Product ID
0407-1413_61f3e388-89bf-43d6-ad51-b620fff561fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iohexol
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL
Labeler
GE Healthcare Inc.
Application
NDA018956
Marketing category
NDA
Marketing start
1985-12-26
Substance
IOHEXOL
Active strength
300 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 32 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0407-1413DDiscontinued by firm2026-09-14
excluded productproduct0407-1413DDiscontinued by firm2026-09-14
excluded productproduct0407-1413DDiscontinued by firm2026-09-14
excluded productproduct0407-1413DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-48DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-41DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-42DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-43DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-46DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-47DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-86DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-87DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-88DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-89DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-68DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-94DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-11DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-30DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-50DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-51DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-60DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-62DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-66DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-69DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-90DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-91DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-92DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-93DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-95DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-96DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-98DDiscontinued by firm2026-09-14
excluded packagepackage0407-14130407-1413-99DDiscontinued by firm2026-09-14

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 6 · 329 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-86d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-62d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-92d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-91d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-89d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-46d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-94d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-66d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-95d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-43d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-51d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-48d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-47d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-87d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-69d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-96d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-41d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-98d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-99d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0407-1413-68d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-86f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-62f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-92f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-93f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-91f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-89f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-46f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-94f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-66f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-95f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-43f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-51f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-48f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-47f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-87f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-69f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-96f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0407-1413-41f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 9 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018956-001OMNIPAQUE 180IOHEXOL38.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-26
N018956-002OMNIPAQUE 240IOHEXOL51.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-26
N018956-003OMNIPAQUE 300IOHEXOL64.7%SOLUTION / INJECTION, ORAL, RECTALAPRLD, RS1985-12-26
N018956-004OMNIPAQUE 350IOHEXOL75.5%SOLUTION / INJECTION, ORALAPRLD, RS1985-12-26
N018956-005OMNIPAQUE 140IOHEXOL30.2%INJECTABLE / INJECTIONRLD, RS1988-11-30
N018956-006OMNIPAQUE 210IOHEXOL45.3%INJECTABLE / INJECTION1989-06-30
N018956-007OMNIPAQUE 70IOHEXOL15.1%SOLUTION / URETHRAL1994-06-01
N018956-008OMNIPAQUE 9IOHEXOL1.9%SOLUTION / ORALRLD, RS2018-04-17
N018956-009OMNIPAQUE 12IOHEXOL2.6%SOLUTION / ORALRLD, RS2018-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018956-003AP
N018956-004AP

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 10 · 387 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018956-001OMNIPAQUE 18038.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-2684e616aacf4f…
2026-09-14 22:38:342026-08N018956-002OMNIPAQUE 24051.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-2684e616aacf4f…
2026-09-14 22:38:342026-08N018956-003OMNIPAQUE 30064.7%SOLUTION / INJECTION, ORAL, RECTALAPRLD, RS1985-12-2684e616aacf4f…
2026-09-14 22:38:342026-08N018956-004OMNIPAQUE 35075.5%SOLUTION / INJECTION, ORALAPRLD, RS1985-12-2684e616aacf4f…
2026-09-14 22:38:342026-08N018956-005OMNIPAQUE 14030.2%INJECTABLE / INJECTIONRLD, RS1988-11-3084e616aacf4f…
2026-09-14 22:38:342026-08N018956-006OMNIPAQUE 21045.3%INJECTABLE / INJECTION1989-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N018956-007OMNIPAQUE 7015.1%SOLUTION / URETHRAL1994-06-0184e616aacf4f…
2026-09-14 22:38:342026-08N018956-008OMNIPAQUE 91.9%SOLUTION / ORALRLD, RS2018-04-1784e616aacf4f…
2026-09-14 22:38:342026-08N018956-009OMNIPAQUE 122.6%SOLUTION / ORALRLD, RS2018-04-1784e616aacf4f…
2026-08-18 06:07:402026-07N018956-001OMNIPAQUE 18038.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07N018956-002OMNIPAQUE 24051.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07N018956-003OMNIPAQUE 30064.7%SOLUTION / INJECTION, ORAL, RECTALAPRLD, RS1985-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07N018956-004OMNIPAQUE 35075.5%SOLUTION / INJECTION, ORALAPRLD, RS1985-12-26caaa826d4ba7…
2026-08-18 06:07:402026-07N018956-005OMNIPAQUE 14030.2%INJECTABLE / INJECTIONRLD, RS1988-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07N018956-006OMNIPAQUE 21045.3%INJECTABLE / INJECTION1989-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07N018956-007OMNIPAQUE 7015.1%SOLUTION / URETHRAL1994-06-01caaa826d4ba7…
2026-08-18 06:07:402026-07N018956-008OMNIPAQUE 91.9%SOLUTION / ORALRLD, RS2018-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07N018956-009OMNIPAQUE 122.6%SOLUTION / ORALRLD, RS2018-04-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018956-001OMNIPAQUE 18038.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018956-002OMNIPAQUE 24051.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018956-003OMNIPAQUE 30064.7%SOLUTION / INJECTION, ORAL, RECTALAPRLD, RS1985-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018956-004OMNIPAQUE 35075.5%SOLUTION / INJECTION, ORALRLD, RS1985-12-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018956-005OMNIPAQUE 14030.2%INJECTABLE / INJECTIONRLD, RS1988-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018956-006OMNIPAQUE 21045.3%INJECTABLE / INJECTION1989-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018956-007OMNIPAQUE 7015.1%SOLUTION / URETHRAL1994-06-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018956-008OMNIPAQUE 91.9%SOLUTION / ORALRLD, RS2018-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018956-009OMNIPAQUE 122.6%SOLUTION / ORALRLD, RS2018-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-001OMNIPAQUE 18038.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-002OMNIPAQUE 24051.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-003OMNIPAQUE 30064.7%SOLUTION / INJECTION, ORAL, RECTALAPRLD, RS1985-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-004OMNIPAQUE 35075.5%SOLUTION / INJECTION, ORALRLD, RS1985-12-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-005OMNIPAQUE 14030.2%INJECTABLE / INJECTIONRLD, RS1988-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-006OMNIPAQUE 21045.3%INJECTABLE / INJECTION1989-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-007OMNIPAQUE 7015.1%SOLUTION / URETHRAL1994-06-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-008OMNIPAQUE 91.9%SOLUTION / ORALRLD, RS2018-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-009OMNIPAQUE 122.6%SOLUTION / ORALRLD, RS2018-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018956-001OMNIPAQUE 18038.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018956-002OMNIPAQUE 24051.8%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018956-003OMNIPAQUE 30064.7%SOLUTION / INJECTION, ORAL, RECTALRLD, RS1985-12-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018956-004OMNIPAQUE 35075.5%SOLUTION / INJECTION, ORALRLD, RS1985-12-266a471c1ec25d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N018956-003AP184e616aacf4f…
2026-09-14 22:38:342026-08N018956-004AP184e616aacf4f…
2026-08-18 06:07:402026-07N018956-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N018956-004AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018956-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018956-003AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018956-003AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018956-004AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
OMNIPAQUE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOHEXOL300 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4419T9MX03Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eee15ebe-d349-4497-acef-6abe7a8247fbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0407-1413-10OMNIPAQUE10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1019
0407-1413-10OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-11OMNIPAQUE10 mL in 1 VIAL, GLASSINJECTION, SOLUTION1019
0407-1413-11OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-30OMNIPAQUE30 mL in 1 VIAL, GLASSINJECTION, SOLUTION3019
0407-1413-30OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-50OMNIPAQUE50 mL in 1 VIAL, GLASSINJECTION, SOLUTION5019
0407-1413-50OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-51OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-51OMNIPAQUE50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5019
0407-1413-53OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-53OMNIPAQUE125 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION12519
0407-1413-59OMNIPAQUE30 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION3019
0407-1413-59OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-60OMNIPAQUE100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10019
0407-1413-60OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-61OMNIPAQUE50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5019
0407-1413-61OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-62OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-62OMNIPAQUE75 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION7519
0407-1413-63OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-63OMNIPAQUE100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10019
0407-1413-65OMNIPAQUE150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15019
0407-1413-65OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-66OMNIPAQUE200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20019
0407-1413-66OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-69OMNIPAQUE125 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION12519
0407-1413-69OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-90OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-90OMNIPAQUE150 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION15019
0407-1413-91OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-91OMNIPAQUE100 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION10019
0407-1413-92OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-92OMNIPAQUE150 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION15019
0407-1413-93OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-93OMNIPAQUE200 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION20019
0407-1413-95OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-95OMNIPAQUE50 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION5019
0407-1413-96OMNIPAQUE100 mL in 1 BOTTLE, GLASSINJECTION, SOLUTION10019
0407-1413-96OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-98OMNIPAQUE50 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION5019
0407-1413-98OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-99OMNIPAQUE10 in 1 BOXINJECTION, SOLUTION1019
0407-1413-99OMNIPAQUE75 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION7519
0407-1413-72Omnipaque500 mL in 1 BOTTLE, PLASTICINJECTION, SOLUTION50013
0407-1413-72Omnipaque10 in 1 BOXINJECTION, SOLUTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0407-1413-10ML - Milliliter0407-1413f6c83663-10b2-42cf-ba83-919bcfb8575a12012-07-24
0407-1413-25ML - Milliliter0407-14139472d196-2be1-4f38-82a1-52d9ae19a50b12013-02-11
0407-1413-30ML - Milliliter0407-14132c267037-b04e-48f3-b582-91d131c571d312012-07-24
0407-1413-41ML - Milliliter0407-1413bbff2ad6-1006-4b74-9487-0e9c70bd569612012-07-24
0407-1413-42ML - Milliliter0407-1413754fe95a-b92f-4f30-8733-ddaa1df19f5712012-07-24
0407-1413-43ML - Milliliter0407-141302470181-9d8b-4b82-a7a5-91a34a54b29512012-07-24
0407-1413-46ML - Milliliter0407-14138f8cf9e8-d727-4142-bcbf-3fdeb213ec9f12012-07-24
0407-1413-47ML - Milliliter0407-141380e65a85-1227-452e-9b41-6add22a9178d12012-07-24
0407-1413-48ML - Milliliter0407-1413ea845e61-aa73-4083-91b4-257223a7894412017-07-07
0407-1413-50ML - Milliliter0407-14136edc5742-30a3-4cef-a21f-903609c2c58d12012-07-24
0407-1413-51ML - Milliliter0407-14133839e2b1-96b7-4464-9b94-37b55138719312012-07-24
0407-1413-53ML - Milliliter0407-141328d83e77-7fec-4c4b-9dbf-e0556acd104012012-07-24
0407-1413-59ML - Milliliter0407-141320d87029-98d0-49e3-97d8-80f255d7354312012-07-24
0407-1413-60ML - Milliliter0407-14137d7b9373-51ef-45b6-b2e5-56db2feb3f4412012-07-24
0407-1413-61ML - Milliliter0407-14136e43222e-60e5-4401-86f3-1e320f019cf512012-07-24
0407-1413-62ML - Milliliter0407-1413324a54b8-5bb1-4e8f-9c6f-aadba9041c6312012-07-24
0407-1413-63ML - Milliliter0407-1413d46dc144-70fb-4b35-b142-d369cdc5dfd112012-07-24
0407-1413-65ML - Milliliter0407-1413bcf1b44c-835a-4165-8a6e-5a5d501334b912012-07-24
0407-1413-66ML - Milliliter0407-14135c118ca6-aadb-40d5-9bef-4ff28c7040d712012-07-24
0407-1413-68ML - Milliliter0407-141379d8c92d-77f1-473c-81a7-733ab192ea5012013-02-13
0407-1413-69ML - Milliliter0407-1413cd1fc263-9cec-4e85-8083-3bf4fd9d23c012021-07-15
0407-1413-72ML - Milliliter0407-14139a50546e-cf70-42ec-a193-4edc9e82f9b412017-03-06
0407-1413-74ML - Milliliter0407-1413e8eb06be-9c29-4034-b7ae-baa935e2d1e112013-02-11
0407-1413-75ML - Milliliter0407-1413258bca6c-dd38-4f1b-82ee-a8a85f5f971212013-02-11
0407-1413-76ML - Milliliter0407-14136cc76b20-eb45-43a8-b2ff-0d0e6c451f6d12013-02-11
0407-1413-86ML - Milliliter0407-14133786bb7f-fd53-4fc9-8df5-9f6e734281c812012-07-24
0407-1413-87ML - Milliliter0407-1413dd082764-64b6-4dbc-b63a-99793887cce012012-07-24
0407-1413-88ML - Milliliter0407-14137e487cb4-f19d-43dc-93ee-988285a1840e12012-07-24
0407-1413-89ML - Milliliter0407-141359a2685c-f6b7-43b9-bc2b-b479e4f7f5b112014-10-03
0407-1413-90ML - Milliliter0407-141336f37e6f-3666-47b5-8ce4-94ab7425fa4b12012-07-24
0407-1413-92ML - Milliliter0407-1413b240bf47-042a-4ed8-b1f4-52cfea7c3e0112013-07-02
0407-1413-98ML - Milliliter0407-14138fe2132b-7de2-4488-af55-2f74e896756412013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IohexolACTIVE INGREDIENT4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
IohexolACTIVE MOIETY4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
hydrochloric acidINACTIVE INGREDIENTQTT17582CBOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
sodium hydroxideINACTIVE INGREDIENT55X04QC32IOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
tromethamineINACTIVE INGREDIENT023C2WHX2VOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]8
IohexolACTIVE INGREDIENT4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
IohexolACTIVE MOIETY4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
Edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFOMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBOMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IOMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
TromethamineINACTIVE INGREDIENT023C2WHX2VOMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE INC.]6
IohexolACTIVE INGREDIENT4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]3
IohexolACTIVE MOIETY4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]3
edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]3
hydrochloric acidINACTIVE INGREDIENTQTT17582CBOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]3
IodineINACTIVE INGREDIENT9679TC07X4OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32IOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]3
tromethamineINACTIVE INGREDIENT023C2WHX2VOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]3
IohexolACTIVE INGREDIENT4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]1
IohexolACTIVE MOIETY4419T9MX03OMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]1
Edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]1
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]1
TromethamineINACTIVE INGREDIENT023C2WHX2VOMNIPAQUE (IOHEXOL) INJECTION [GE HEALTHCARE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0407-1413OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.]18Current NDC, Legacy NDC, 44 package rows20241024_eee15ebe-d349-4497-acef-6abe7a8247fb.zip
0407-1413OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE]11Current NDC, Legacy NDC, 2 package rows20241020_164b27b9-97ae-4279-896f-1c4afa583dd1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMNIPAQUEIOHEXOLMedical Purchasing Solutions, LLC5088be1d-a708-1cac-e063-6394a90a2aff2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018956
application number: NDA018956
OMNIPAQUEIOHEXOLMedical Purchasing Solutions, LLC508c42eb-f5e5-44f1-e063-6294a90a4d1f2026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018956
application number: NDA018956
OMNIPAQUEIOHEXOLGE Healthcare Inc.eee15ebe-d349-4497-acef-6abe7a8247fb2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018956
application number: NDA018956
ndc (product): 0407-1413
OmnipaqueIOHEXOLGE Healthcare164b27b9-97ae-4279-896f-1c4afa583dd12026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0407-1413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0407-1413-100040714131010 VIAL, GLASS in 1 BOX (0407-1413-10) / 10 mL in 1 VIAL, GLASS1985-12-260000-00-00NoNoCurrent
0407-1413-110040714131110 mL in 1 VIAL, GLASS10 mlHistorical
0407-1413-300040714133030 mL in 1 VIAL, GLASS30 mlHistorical
0407-1413-410040714134110 VIAL in 1 BOX (0407-1413-41) > 50 mL in 1 VIAL10 vial2006-09-210000-00-00NoNoCurrent
0407-1413-420040714134210 BOTTLE in 1 BOX (0407-1413-42) > 50 mL in 1 BOTTLE10 bottle2006-09-210000-00-00NoNoCurrent
0407-1413-430040714134310 BOTTLE in 1 BOX (0407-1413-43) > 100 mL in 1 BOTTLE10 bottle2006-09-210000-00-00NoNoCurrent
0407-1413-460040714134610 BOTTLE in 1 BOX (0407-1413-46) > 150 mL in 1 BOTTLE10 bottle2006-09-210000-00-00NoNoCurrent
0407-1413-470040714134710 BOTTLE in 1 BOX (0407-1413-47) > 125 mL in 1 BOTTLE10 bottle2006-09-210000-00-00NoNoCurrent
0407-1413-480040714134810 BOTTLE, PLASTIC in 1 BOX (0407-1413-48) > 500 mL in 1 BOTTLE, PLASTIC2016-12-210000-00-00NoNoCurrent
0407-1413-500040714135050 mL in 1 VIAL, GLASS50 mlHistorical
0407-1413-510040714135110 in 1 BOXHistorical
0407-1413-530040714135310 BOTTLE, GLASS in 1 BOX (0407-1413-53) / 125 mL in 1 BOTTLE, GLASS1985-12-260000-00-00NoNoCurrent
0407-1413-590040714135910 BOTTLE, PLASTIC in 1 BOX (0407-1413-59) / 30 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-6000407141360100 mL in 1 BOTTLE, GLASS100 mlHistorical
0407-1413-610040714136110 BOTTLE, PLASTIC in 1 BOX (0407-1413-61) / 50 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-620040714136210 BOTTLE, PLASTIC in 1 BOX (0407-1413-62) > 75 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-630040714136310 BOTTLE, PLASTIC in 1 BOX (0407-1413-63) / 100 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-650040714136510 BOTTLE, PLASTIC in 1 BOX (0407-1413-65) / 150 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-660040714136610 BOTTLE, PLASTIC in 1 BOX (0407-1413-66) > 200 mL in 1 BOTTLE, PLASTIC1985-12-260000-00-00NoNoCurrent
0407-1413-680040714136810 BOTTLE, PLASTIC in 1 BOX (0407-1413-68) > 500 mL in 1 BOTTLE, PLASTIC2004-09-030000-00-00NoNoCurrent
0407-1413-690040714136910 BOTTLE, PLASTIC in 1 BOX (0407-1413-69) > 125 mL in 1 BOTTLE, PLASTIC2020-03-230000-00-00NoNoCurrent
0407-1413-720040714137210 BOTTLE, PLASTIC in 1 BOX (0407-1413-72) / 500 mL in 1 BOTTLE, PLASTIC2016-12-210000-00-00NoNoCurrent
0407-1413-860040714138610 BOTTLE, PLASTIC in 1 BOX (0407-1413-86) > 50 mL in 1 BOTTLE, PLASTIC2006-09-210000-00-00NoNoCurrent
0407-1413-870040714138710 BOTTLE, PLASTIC in 1 BOX (0407-1413-87) > 100 mL in 1 BOTTLE, PLASTIC2006-09-210000-00-00NoNoCurrent
0407-1413-880040714138810 BOTTLE, PLASTIC in 1 BOX (0407-1413-88) > 150 mL in 1 BOTTLE, PLASTIC2006-09-210000-00-00NoNoCurrent
0407-1413-890040714138910 BOTTLE, PLASTIC in 1 BOX (0407-1413-89) > 500 mL in 1 BOTTLE, PLASTIC2005-08-032024-10-22NoNoCurrent
0407-1413-900040714139010 in 1 BOXHistorical
0407-1413-910040714139110 in 1 BOXHistorical
0407-1413-920040714139210 in 1 BOXHistorical
0407-1413-930040714139310 in 1 BOXHistorical
0407-1413-950040714139510 in 1 BOXHistorical
0407-1413-9600407141396100 mL in 1 BOTTLE, GLASS100 mlHistorical
0407-1413-980040714139850 mL in 1 BOTTLE, PLASTIC50 mlHistorical
0407-1413-990040714139910 in 1 BOXHistorical