Indium DTPA In 111

Product NDC
17156-251
11-digit product format
171560251
Labeler code
17156
Product ID
17156-251_3dfabc30-f669-4287-9948-038c3a502d1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indium In-111 Pentetate Disodium
Dosage form
SOLUTION
Route
INTRATHECAL
Labeler
Medi-Physics, Inc. dba GE Healthcare
Application
NDA017707
Marketing category
NDA
Marketing start
1982-02-18
Substance
INDIUM IN-111 PENTETATE DISODIUM
Active strength
1 mCi/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
N017707-001MPI INDIUM DTPA IN 111INDIUM IN-111 PENTETATE DISODIUM1mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18

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 06:07:402026-07N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-183f01610625f2…
2019-09-15 20:21 UTC2019-09N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017707-001MPI INDIUM DTPA IN 1111mCi/MLINJECTABLE / INTRATHECALRLD, RS1982-02-18e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Indium DTPA In 111
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDIUM IN-111 PENTETATE DISODIUM1 mCi/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7UIT3ZGC8EInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4fea5871-b515-4f69-a297-11507ddd7817Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43055ffe-41d2-43bd-8a82-6a956e857831Product name220250304
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
bbd6bead-5f01-4935-a7c1-b17c43e7374cProduct name120181004
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d68e438a-7784-467d-ad60-7eef2f560f15Product name120151118
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17156-251-08Indium DTPA In 1111.5 mL in 1 VIAL, GLASSSOLUTION1.56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17156-251-08EA - Each17156-251d03120e1-9499-48b1-87c2-f8088cd5462622022-11-07

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17156-251INDIUM DTPA IN 111 (INDIUM IN-111 PENTETATE DISODIUM) SOLUTION [MEDI-PHYSICS, INC. DBA GE HEALTHCARE]6Current NDC, Legacy NDC, 1 package rows20240112_4fea5871-b515-4f69-a297-11507ddd7817.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 DTPA In 111INDIUM IN-111 PENTETATE DISODIUMMedi-Physics, Inc. dba GE Healthcare4fea5871-b515-4f69-a297-11507ddd78172024-01-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 017707
application number: NDA017707
ndc (product): 17156-251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17156-251-08171560251081.5 mL in 1 VIAL, GLASS (17156-251-08) 1.5 ml1982-02-180000-00-00NoNoCurrent