Home NDC 0409-1401 Regadenoson
Product NDC 0409-1401
11-digit product format 004091401
Labeler code 0409
Product ID 0409-1401_67995dbc-0e79-4b3b-a6f8-eaeb5048ff3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Regadenoson
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA214349
Marketing category ANDA
Marketing start 2023-03-01
Substance REGADENOSON ANHYDROUS
Active strength .08 mg/mL
Pharmacologic classes Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]
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 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product 0409-1401 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-1401 0409-1401-01 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A214349-001 REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214349-001 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.
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 2026-02-19 14:30 UTC 2026-02 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214349-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-08-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Regadenoson
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength REGADENOSON ANHYDROUS .08 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7AXV542LZ4 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 0409-1401-01 Regadenoson 10 in 1 PACKAGE INJECTION, SOLUTION 10 4 0409-1401-01 Regadenoson 1 in 1 CARTON INJECTION, SOLUTION 1 4 0409-1401-05 Regadenoson 5 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1401 REGADENOSON INJECTION, SOLUTION [HOSPIRA, INC.] 3 Current NDC, 3 package rows 20240731_0e3f080d-b1fb-47ed-8cd3-90a4206fa704.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 Units Marketing start Sample Exclude flag Status 0409-1401-01 00409140101 10 CARTON in 1 PACKAGE (0409-1401-01) / 1 SYRINGE, PLASTIC in 1 CARTON / 5 mL in 1 SYRINGE, PLASTIC (0409-1401-05) 10 carton 2023-03-01 No No Current 0409-1401-05 00409140105 5 mL in 1 SYRINGE, PLASTIC 5 ml Historical