Home NDC 0019-1333 Optiray
Product NDC 0019-1333
11-digit product format 000191333
Labeler code 0019
Product ID 0019-1333_1884aaeb-c174-4df7-a710-82d2b1869ad2
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
Substance IOVERSOL
Active strength 741 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 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019710-001 OPTIRAY 320 IOVERSOL 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 N019710-002 OPTIRAY 240 IOVERSOL 51% INJECTABLE / INJECTION RLD 1988-12-30 N019710-003 OPTIRAY 160 IOVERSOL 34% INJECTABLE / INJECTION 1988-12-30 N019710-004 OPTIRAY 300 IOVERSOL 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 N019710-005 OPTIRAY 350 IOVERSOL 74% INJECTABLE / INJECTION RLD, RS 1992-01-22
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 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 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 03ed91905a0d…
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 Optiray
Brand name suffix 350
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOVERSOL 741 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N3RIB7X24K Internal UNII 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 0019-1333-00 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-00 Optiray350 100 mL in 1 SYRINGE, PLASTIC INJECTION 100 50 0019-1333-06 Optiray350 25 in 1 CARTON INJECTION 25 50 0019-1333-06 Optiray350 50 mL in 1 BOTTLE, GLASS INJECTION 50 50 0019-1333-11 Optiray350 100 mL in 1 BOTTLE, GLASS INJECTION 100 50 0019-1333-11 Optiray350 12 in 1 CARTON INJECTION 12 50 0019-1333-16 Optiray350 12 in 1 CARTON INJECTION 12 50 0019-1333-16 Optiray350 150 mL in 1 BOTTLE, GLASS INJECTION 150 50 0019-1333-21 Optiray350 200 mL in 1 BOTTLE, GLASS INJECTION 200 50 0019-1333-21 Optiray350 12 in 1 CARTON INJECTION 12 50 0019-1333-27 Optiray350 125 mL in 1 SYRINGE, PLASTIC INJECTION 125 50 0019-1333-27 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-52 Optiray350 50 mL in 1 SYRINGE, PLASTIC INJECTION 50 50 0019-1333-52 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-55 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-55 Optiray350 50 mL in 1 SYRINGE, PLASTIC INJECTION 50 50 0019-1333-75 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-75 Optiray350 50 mL in 1 SYRINGE, PLASTIC INJECTION 50 50 0019-1333-77 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-77 Optiray350 50 mL in 1 SYRINGE, PLASTIC INJECTION 50 50 0019-1333-78 Optiray350 50 mL in 1 SYRINGE, PLASTIC INJECTION 50 50 0019-1333-78 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-81 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-81 Optiray350 125 mL in 1 SYRINGE, PLASTIC INJECTION 125 50 0019-1333-83 Optiray350 100 mL in 1 SYRINGE, PLASTIC INJECTION 100 50 0019-1333-83 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-85 Optiray350 75 mL in 1 SYRINGE, PLASTIC INJECTION 75 50 0019-1333-85 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-87 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-87 Optiray350 125 mL in 1 SYRINGE, PLASTIC INJECTION 125 50 0019-1333-90 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-90 Optiray350 100 mL in 1 SYRINGE, PLASTIC INJECTION 100 50 0019-1333-91 Optiray350 75 mL in 1 SYRINGE, PLASTIC INJECTION 75 50 0019-1333-91 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-95 Optiray350 20 in 1 CARTON INJECTION 20 50 0019-1333-95 Optiray350 75 mL in 1 SYRINGE, PLASTIC INJECTION 75 50 0019-1333-51 Optiray350 12 in 1 CARTON INJECTION 12 39 0019-1333-51 Optiray350 250 mL in 1 BOTTLE, GLASS INJECTION 250 39 0019-1333-61 Optiray350 500 mL in 1 BOTTLE, GLASS INJECTION 500 39 0019-1333-61 Optiray350 6 in 1 CARTON INJECTION 6 39 0019-1333-65 Optiray350 6 in 1 CARTON INJECTION 6 7 0019-1333-65 Optiray350 500 mL in 1 BOTTLE, GLASS INJECTION 500 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0019-1333 OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC] 50 Current NDC, Legacy NDC, 36 package rows 20230606_549d38db-d4ed-4708-8f76-7cdaa157063f.zip 0019-1333 OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC] 36 Current NDC, Legacy NDC, 4 package rows 20230615_6cb6ca5f-b249-49b0-a9eb-8aa583da7c74.zip 0019-1333 OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC] 3 Current NDC, Legacy NDC, 2 package rows 20230615_cd718d1c-f813-4114-a50d-c744ff7eb1bf.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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0019-1333-00 00019133300 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-00) / 100 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-06 00019133306 25 BOTTLE, GLASS in 1 CARTON (0019-1333-06) / 50 mL in 1 BOTTLE, GLASS 2012-03-04 0000-00-00 No No Current 0019-1333-11 00019133311 12 BOTTLE, GLASS in 1 CARTON (0019-1333-11) / 100 mL in 1 BOTTLE, GLASS 2012-03-04 0000-00-00 No No Current 0019-1333-16 00019133316 12 BOTTLE, GLASS in 1 CARTON (0019-1333-16) / 150 mL in 1 BOTTLE, GLASS 2012-03-04 0000-00-00 No No Current 0019-1333-21 00019133321 12 BOTTLE, GLASS in 1 CARTON (0019-1333-21) / 200 mL in 1 BOTTLE, GLASS 2012-03-04 0000-00-00 No No Current 0019-1333-27 00019133327 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-27) / 125 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-51 00019133351 12 BOTTLE, GLASS in 1 CARTON (0019-1333-51) / 250 mL in 1 BOTTLE, GLASS 2011-10-17 0000-00-00 No No Current 0019-1333-52 00019133352 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-52) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-55 00019133355 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-55) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-61 00019133361 6 BOTTLE, GLASS in 1 CARTON (0019-1333-61) / 500 mL in 1 BOTTLE, GLASS 2011-10-17 0000-00-00 No No Current 0019-1333-65 00019133365 6 BOTTLE, GLASS in 1 CARTON (0019-1333-65) / 500 mL in 1 BOTTLE, GLASS 2020-11-18 0000-00-00 No No Current 0019-1333-75 00019133375 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-75) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-77 00019133377 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-77) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-78 00019133378 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-78) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-81 00019133381 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-81) / 125 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-83 00019133383 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-83) / 100 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-85 00019133385 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-85) / 75 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-87 00019133387 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-87) / 125 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-90 00019133390 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-90) / 100 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-91 00019133391 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-91) / 75 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1333-95 00019133395 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-95) / 75 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current