Indium in 111 Oxyquinoline

Product NDC
17156-021
11-digit product format
171560021
Labeler code
17156
Product ID
17156-021_bc294a45-4008-4476-b7a4-9475b18d43a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indium In-111 Oxyquinoline
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Medi-Physics Inc. dba GE Healthcare.
Application
NDA019044
Marketing category
NDA
Marketing start
1985-12-01
Substance
INDIUM IN-111 OXYQUINOLINE
Active strength
1 ug/mL
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019044-001INDIUM IN 111 OXYQUINOLINEINDIUM IN-111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019044-001AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONRLD, RS1985-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONRLD, RS1985-12-243f01610625f2…
2019-09-15 20:21 UTC2019-09N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONRLD, RS1985-12-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONRLD, RS1985-12-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019044-001INDIUM IN 111 OXYQUINOLINE1mCi/MLINJECTABLE / INJECTIONAPRLD, RS1985-12-24e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N019044-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019044-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019044-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019044-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019044-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019044-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019044-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019044-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019044-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019044-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019044-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019044-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019044-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019044-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019044-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019044-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019044-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019044-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N019044-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019044-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019044-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N019044-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019044-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019044-001AP1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019044-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019044-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019044-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019044-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019044-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019044-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019044-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019044-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019044-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019044-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019044-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019044-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019044-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019044-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Indium in 111 Oxyquinoline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDIUM IN-111 OXYQUINOLINE1 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LGX9OL562TInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c52c904-8137-4b10-8a85-d9b96c2d8a00Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43055ffe-41d2-43bd-8a82-6a956e857831Product name220250304
bbd6bead-5f01-4935-a7c1-b17c43e7374cProduct name120181004
d68e438a-7784-467d-ad60-7eef2f560f15Product name120151118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17156-021-01Indium in 111 Oxyquinoline1 in 1 BOXSOLUTION19
17156-021-01Indium in 111 Oxyquinoline1 mL in 1 VIALSOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17156-021-01EA - Each17156-021febc748d-9511-45cb-a9e5-a8c0bf932b6422022-11-07

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17156-021INDIUM IN 111 OXYQUINOLINE (INDIUM IN-111 OXYQUINOLINE) SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.]9Current NDC, Legacy NDC, 2 package rows20240112_4c52c904-8137-4b10-8a85-d9b96c2d8a00.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Indium in 111 OxyquinolineINDIUM IN-111 OXYQUINOLINEMedi-Physics Inc. dba GE Healthcare.4c52c904-8137-4b10-8a85-d9b96c2d8a002024-01-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019044
application number: NDA019044
ndc (product): 17156-021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17156-021-01171560021011 VIAL in 1 BOX (17156-021-01) / 1 mL in 1 VIAL1 vial1985-12-010000-00-00NoNoCurrent