Home NDC 65174-288 DRAXIMAGE DTPA
Product NDC 65174-288
11-digit product format 651740288
Labeler code 65174
Product ID 65174-288_ea90e623-af26-4014-a0c3-3fe5d753a5e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Kit for the preparation of Technetium Tc 99m Pentetate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; RESPIRATORY (INHALATION)
Labeler Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application NDA018511
Marketing category NDA
Marketing start 1989-12-29
Substance PENTETIC ACID
Active strength 20 mg/1
Pharmacologic classes Lead Chelating Activity [MoA], Lead Chelator [EPC]
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018511-001 DRAXIMAGE DTPA TECHNETIUM TC-99M PENTETATE KIT N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018511-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION AP RLD, RS 1989-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018511-001 DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018511-001 DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018511-001 DRAXIMAGE DTPA N/A INJECTABLE / INJECTION RLD, RS 1989-12-29 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base DRAXIMAGE DTPA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENTETIC ACID 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7A314HQM0I 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 65174-288-30 DRAXIMAGE DTPA 30 in 1 KIT INJECTION, POWDER, LYOPHILIZED, 30 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65174-288 DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA] 8 Current NDC, Legacy NDC, 1 package rows 20230615_becdab53-f7a7-7280-6930-21f3a61b99e7.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DRAXIMAGE DTPA KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE Jubilant DraxImage Inc., dba Jubilant Radiopharma becdab53-f7a7-7280-6930-21f3a61b99e7 2023-05-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 018511 application number: NDA018511 ndc (product): 65174-288
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65174-288-05 65174028805 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-05) 1989-12-29 0000-00-00 No No Current 65174-288-30 65174028830 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30) 1989-12-29 0000-00-00 No No Current