Home NDC 65174-021 RUBY-FILL
Product NDC 65174-021
11-digit product format 651740021
Labeler code 65174
Product ID 65174-021_efb00947-c7d1-4fc8-8ca0-24d80952b7ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rubidium Rb 82
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Jubilant DraxImage Inc., dba Jubilant Radiopharma
Application NDA202153
Marketing category NDA
Marketing start 2016-09-30
Substance RUBIDIUM CHLORIDE RB-82
Active strength 100 mCi/1
Pharmacologic classes Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
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 N202153-001 RUBY-FILL RUBIDIUM CHLORIDE RB-82 N/A SOLUTION / INTRAVENOUS 2016-09-30
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 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202153-001 RUBY-FILL N/A SOLUTION / INTRAVENOUS 2016-09-30 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base RUBY-FILL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RUBIDIUM CHLORIDE RB-82 100 mCi/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F0Z746KRKQ 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 65174-021-10 RUBY-FILL 1 in 1 CONTAINER INJECTION, SOLUTION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65174-021 RUBY-FILL (RUBIDIUM RB 82) INJECTION, SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA] 8 Current NDC, Legacy NDC, 1 package rows 20201201_b3c0cc0c-2f4b-4e08-8a84-3cb77473c2e8.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 RUBY-FILL RUBIDIUM RB 82 Jubilant DraxImage Inc., dba Jubilant Radiopharma b3c0cc0c-2f4b-4e08-8a84-3cb77473c2e8 2020-10-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202153 application number: NDA202153 ndc (product): 65174-021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65174-021-10 65174002110 1 INJECTION, SOLUTION in 1 CONTAINER (65174-021-10) 2016-09-30 0000-00-00 No No Current