Home DailyMed 74249ff7-e5f4-41df-91ef-e52d4fc0ead1 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:03:35
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 5 of 6 · 220 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 2023-12-20 04:57 UTC 2023-12 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019710-001 OPTIRAY 320 68% INJECTABLE / INJECTION RLD, RS 1988-12-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019710-002 OPTIRAY 240 51% INJECTABLE / INJECTION RLD 1988-12-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019710-003 OPTIRAY 160 34% INJECTABLE / INJECTION 1988-12-30 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019710-004 OPTIRAY 300 64% INJECTABLE / INJECTION RLD, RS 1992-01-22 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019710-005 OPTIRAY 350 74% INJECTABLE / INJECTION RLD, RS 1992-01-22 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.