Optiray

Product NDC
0019-1324
Requested package NDC
0019-1324-06
11-digit product format
000191324
Labeler code
0019
Product ID
0019-1324_e4a36c3b-837e-48da-abb4-498cdf3c7079
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ioversol
Dosage form
INJECTION
Route
INTRA-ARTERIAL; INTRAVENOUS
Labeler
Liebel-Flarsheim Company LLC
Application
NDA019710
Marketing category
NDA
Marketing start
2012-03-04
Marketing end
0000-00-00
Substance
IOVERSOL
Active strength
509 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0019-13240019-1324-06DDiscontinued by firm2026-10-05

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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019710-001OPTIRAY 320IOVERSOL68%INJECTABLE / INJECTIONRLD, RS1988-12-30
N019710-002OPTIRAY 240IOVERSOL51%INJECTABLE / INJECTIONRLD1988-12-30
N019710-003OPTIRAY 160IOVERSOL34%INJECTABLE / INJECTION1988-12-30
N019710-004OPTIRAY 300IOVERSOL64%INJECTABLE / INJECTIONRLD, RS1992-01-22
N019710-005OPTIRAY 350IOVERSOL74%INJECTABLE / INJECTIONRLD, RS1992-01-22

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019710-001OPTIRAY 32068%INJECTABLE / INJECTIONRLD, RS1988-12-3084e616aacf4f…
2026-09-14 22:38:342026-08N019710-002OPTIRAY 24051%INJECTABLE / INJECTIONRLD1988-12-3084e616aacf4f…
2026-09-14 22:38:342026-08N019710-003OPTIRAY 16034%INJECTABLE / INJECTION1988-12-3084e616aacf4f…
2026-09-14 22:38:342026-08N019710-004OPTIRAY 30064%INJECTABLE / INJECTIONRLD, RS1992-01-2284e616aacf4f…
2026-09-14 22:38:342026-08N019710-005OPTIRAY 35074%INJECTABLE / INJECTIONRLD, RS1992-01-2284e616aacf4f…
2026-08-18 06:07:402026-07N019710-001OPTIRAY 32068%INJECTABLE / INJECTIONRLD, RS1988-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07N019710-002OPTIRAY 24051%INJECTABLE / INJECTIONRLD1988-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07N019710-003OPTIRAY 16034%INJECTABLE / INJECTION1988-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07N019710-004OPTIRAY 30064%INJECTABLE / INJECTIONRLD, RS1992-01-22caaa826d4ba7…
2026-08-18 06:07:402026-07N019710-005OPTIRAY 35074%INJECTABLE / INJECTIONRLD, RS1992-01-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019710-001OPTIRAY 32068%INJECTABLE / INJECTIONRLD, RS1988-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019710-002OPTIRAY 24051%INJECTABLE / INJECTIONRLD1988-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019710-003OPTIRAY 16034%INJECTABLE / INJECTION1988-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019710-004OPTIRAY 30064%INJECTABLE / INJECTIONRLD, RS1992-01-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019710-005OPTIRAY 35074%INJECTABLE / INJECTIONRLD, RS1992-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019710-001OPTIRAY 32068%INJECTABLE / INJECTIONRLD, RS1988-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019710-002OPTIRAY 24051%INJECTABLE / INJECTIONRLD1988-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019710-003OPTIRAY 16034%INJECTABLE / INJECTION1988-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019710-004OPTIRAY 30064%INJECTABLE / INJECTIONRLD, RS1992-01-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019710-005OPTIRAY 35074%INJECTABLE / INJECTIONRLD, RS1992-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N019710-001OPTIRAY 32068%INJECTABLE / INJECTIONRLD, RS1988-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019710-002OPTIRAY 24051%INJECTABLE / INJECTIONRLD1988-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019710-003OPTIRAY 16034%INJECTABLE / INJECTION1988-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019710-004OPTIRAY 30064%INJECTABLE / INJECTIONRLD, RS1992-01-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019710-005OPTIRAY 35074%INJECTABLE / INJECTIONRLD, RS1992-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019710-001OPTIRAY 32068%INJECTABLE / INJECTIONRLD, RS1988-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019710-002OPTIRAY 24051%INJECTABLE / INJECTIONRLD1988-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019710-003OPTIRAY 16034%INJECTABLE / INJECTION1988-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019710-004OPTIRAY 30064%INJECTABLE / INJECTIONRLD, RS1992-01-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019710-005OPTIRAY 35074%INJECTABLE / INJECTIONRLD, RS1992-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019710-001OPTIRAY 32068%INJECTABLE / INJECTIONRLD, RS1988-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019710-002OPTIRAY 24051%INJECTABLE / INJECTIONRLD1988-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019710-003OPTIRAY 16034%INJECTABLE / INJECTION1988-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019710-004OPTIRAY 30064%INJECTABLE / INJECTIONRLD, RS1992-01-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019710-005OPTIRAY 35074%INJECTABLE / INJECTIONRLD, RS1992-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019710-001OPTIRAY 32068%INJECTABLE / INJECTIONRLD, RS1988-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019710-002OPTIRAY 24051%INJECTABLE / INJECTIONRLD1988-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019710-003OPTIRAY 16034%INJECTABLE / INJECTION1988-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019710-004OPTIRAY 30064%INJECTABLE / INJECTIONRLD, RS1992-01-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019710-005OPTIRAY 35074%INJECTABLE / INJECTIONRLD, RS1992-01-2203ed91905a0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0019-1324-06ML - Milliliter0019-13242237ee2a-bcc6-4ec6-a8e2-f2bd13dbac7612012-07-24
0019-1324-11ML - Milliliter0019-1324ea96ae50-9f90-4654-aea8-ca6739688f6a12012-07-24
0019-1324-16ML - Milliliter0019-1324970e0bb7-4673-4584-8421-39d8a1e623bb12012-07-24
0019-1324-21ML - Milliliter0019-13244938ce8b-dc8c-407d-9aaf-ebd7c8ed488d12012-07-24
0019-1324-75ML - Milliliter0019-13248cd4dfc5-6991-44e0-8aaa-ebad8c5164f412012-07-24
0019-1324-78ML - Milliliter0019-1324cb587c60-64ac-47da-b47a-7a8c03b5423412013-02-13
0019-1324-81ML - Milliliter0019-132431746382-7f37-4f3a-8d75-ad9994cebaae12012-07-24
0019-1324-87ML - Milliliter0019-13245b418cb5-27aa-4dc5-bdf9-a7a0e9d5bac812018-01-12

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
Optiray 320IOVERSOLLiebel-Flarsheim Company LLC549d38db-d4ed-4708-8f76-7cdaa157063f2023-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019710
application number: NDA019710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0019-1324-060001913240625 BOTTLE, GLASS in 1 CARTON (0019-1324-06) > 50 mL in 1 BOTTLE, GLASS2012-03-040000-00-00NoNoCurrent