Home NDC 0270-0091 CardioGen-82
Product NDC 0270-0091
11-digit product format 002700091
Labeler code 0270
Product ID 0270-0091_990b8a5b-d1f5-2119-1e01-cdccdcb607ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rubidium Chloride RB-82
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Bracco Diagnostics Inc
Application NDA019414
Marketing category NDA
Marketing start 1989-12-30
Substance RUBIDIUM CHLORIDE RB-82
Active strength 150 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 0270-0091 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0270-0091 0270-0091-01 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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 N019414-001 CARDIOGEN-82 RUBIDIUM CHLORIDE RB-82 N/A INJECTABLE / INJECTION 1989-12-29
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 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019414-001 CARDIOGEN-82 N/A INJECTABLE / INJECTION 1989-12-29 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base CardioGen-82
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RUBIDIUM CHLORIDE RB-82 150 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0270-0091-01 CardioGen-82 1 in 1 PACKAGE INJECTION, SOLUTION 1 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-0091 CARDIOGEN-82 (RUBIDIUM CHLORIDE RB-82) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 18 Current NDC, Legacy NDC, 1 package rows 20250129_ee95aa18-9f2f-40eb-9b4c-583bea6f36bf.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 0270-0091-01 00270009101 1 INJECTION, SOLUTION in 1 PACKAGE (0270-0091-01) 1989-12-30 0000-00-00 No No Current