Home NDC 0019-1332 Optiray
Product NDC 0019-1332
11-digit product format 000191332
Labeler code 0019
Product ID 0019-1332_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 636 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 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0019-1332-61 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0019-1332-61 f5e01cc5f278…a2eaf40c39c3…
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 300
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOVERSOL 636 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 0019-1332-00 Optiray300 100 mL in 1 SYRINGE, PLASTIC INJECTION 100 50 0019-1332-00 Optiray300 20 in 1 CARTON INJECTION 20 50 0019-1332-06 Optiray300 25 in 1 CARTON INJECTION 25 50 0019-1332-06 Optiray300 50 mL in 1 BOTTLE, GLASS INJECTION 50 50 0019-1332-11 Optiray300 12 in 1 CARTON INJECTION 12 50 0019-1332-11 Optiray300 100 mL in 1 BOTTLE, GLASS INJECTION 100 50 0019-1332-16 Optiray300 150 mL in 1 BOTTLE, GLASS INJECTION 150 50 0019-1332-16 Optiray300 12 in 1 CARTON INJECTION 12 50 0019-1332-21 Optiray300 200 mL in 1 BOTTLE, GLASS INJECTION 200 50 0019-1332-21 Optiray300 12 in 1 CARTON INJECTION 12 50 0019-1332-75 Optiray300 50 mL in 1 SYRINGE, PLASTIC INJECTION 50 50 0019-1332-75 Optiray300 20 in 1 CARTON INJECTION 20 50 0019-1332-78 Optiray300 20 in 1 CARTON INJECTION 20 50 0019-1332-78 Optiray300 50 mL in 1 SYRINGE, PLASTIC INJECTION 50 50 0019-1332-83 Optiray300 100 mL in 1 SYRINGE, PLASTIC INJECTION 100 50 0019-1332-83 Optiray300 20 in 1 CARTON INJECTION 20 50 0019-1332-90 Optiray300 100 mL in 1 SYRINGE, PLASTIC INJECTION 100 50 0019-1332-90 Optiray300 20 in 1 CARTON INJECTION 20 50 0019-1332-91 Optiray300 75 mL in 1 SYRINGE, PLASTIC INJECTION 75 50 0019-1332-91 Optiray300 20 in 1 CARTON INJECTION 20 50 0019-1332-61 Optiray300 500 mL in 1 BOTTLE, GLASS INJECTION 500 39 0019-1332-61 Optiray300 6 in 1 CARTON INJECTION 6 39 0019-1332-65 Optiray300 6 in 1 CARTON INJECTION 6 7 0019-1332-65 Optiray300 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 0019-1332 OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC] 50 Current NDC, Legacy NDC, 20 package rows 20230606_549d38db-d4ed-4708-8f76-7cdaa157063f.zip 0019-1332 OPTIRAY 350 (IOVERSOL) INJECTION OPTIRAY 320 (IOVERSOL) INJECTION OPTIRAY 300 (IOVERSOL) INJECTION [LIEBEL-FLARSHEIM COMPANY LLC] 36 Current NDC, Legacy NDC, 2 package rows 20230615_6cb6ca5f-b249-49b0-a9eb-8aa583da7c74.zip 0019-1332 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 0019-1332-00 00019133200 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-00) / 100 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1332-06 00019133206 25 BOTTLE, GLASS in 1 CARTON (0019-1332-06) / 50 mL in 1 BOTTLE, GLASS 2012-03-04 0000-00-00 No No Current 0019-1332-11 00019133211 12 BOTTLE, GLASS in 1 CARTON (0019-1332-11) / 100 mL in 1 BOTTLE, GLASS 2012-03-04 0000-00-00 No No Current 0019-1332-16 00019133216 12 BOTTLE, GLASS in 1 CARTON (0019-1332-16) / 150 mL in 1 BOTTLE, GLASS 2012-03-04 0000-00-00 No No Current 0019-1332-21 00019133221 12 BOTTLE, GLASS in 1 CARTON (0019-1332-21) / 200 mL in 1 BOTTLE, GLASS 2012-03-04 0000-00-00 No No Current 0019-1332-61 00019133261 6 BOTTLE, GLASS in 1 CARTON (0019-1332-61) > 500 mL in 1 BOTTLE, GLASS 2011-10-17 0000-00-00 No No Current 0019-1332-65 00019133265 6 BOTTLE, GLASS in 1 CARTON (0019-1332-65) > 500 mL in 1 BOTTLE, GLASS 2020-11-18 0000-00-00 No No Current 0019-1332-75 00019133275 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-75) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1332-78 00019133278 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-78) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1332-83 00019133283 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-83) / 100 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1332-90 00019133290 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-90) / 100 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current 0019-1332-91 00019133291 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-91) / 75 mL in 1 SYRINGE, PLASTIC 2012-03-04 0000-00-00 No No Current