Home NDC 65174-660 Technetium Tc 99m Medronate
Product NDC 65174-660
11-digit product format 651740660
Labeler code 65174
Product ID 65174-660_71674538-1da8-436f-be11-7e964a2c5b05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Technetium Tc 99m Medronate
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application NDA018035
Marketing category NDA
Marketing start 2004-02-27
Substance MEDRONIC ACID
Active strength 25 mg/1
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018035-001 DRAXIMAGE MDP-10 TECHNETIUM TC-99M MEDRONATE N/A INJECTABLE / INJECTION Approved before 1982 N018035-002 DRAXIMAGE MDP-25 TECHNETIUM TC-99M MEDRONATE N/A INJECTABLE / INJECTION RLD, RS 2004-02-27
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 3 · 86 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 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018035-001 DRAXIMAGE MDP-10 N/A INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018035-002 DRAXIMAGE MDP-25 N/A INJECTABLE / INJECTION RLD, RS 2004-02-27 74a2ff9319b5…
Additional Listing Data#
Finished product Yes
Brand name base Technetium Tc 99m Medronate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEDRONIC ACID 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 73OS0QIN3O Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65174-660-30 Technetium Tc 99m Medronate 30 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 30 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Medronic Acid ACTIVE INGREDIENT 73OS0QIN3O TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC] 1 Medronic Acid ACTIVE MOIETY 73OS0QIN3O TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC] 1 Aminobenzoic Acid INACTIVE INGREDIENT TL2TJE8QTX TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC] 1 Stannous Chloride INACTIVE INGREDIENT 1BQV3749L5 TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65174-660 TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, FOR SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA] 3 Current NDC, Legacy NDC, 1 package rows 20200826_3c91d0d8-6cc5-834c-bda0-aa83a873b9fb.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65174-660-30 65174066030 30 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (65174-660-30) 2004-02-27 0000-00-00 No No Current