Home NDC 68083-175 Regadenoson
Product NDC 68083-175
11-digit product format 680830175
Labeler code 68083
Product ID 68083-175_549593f6-8cfc-4182-8f3c-a60870187d8f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Regadenoson
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA207320
Marketing category ANDA
Marketing start 2022-07-12
Substance REGADENOSON
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 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 A207320-001 REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207320-001 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 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207320-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2022-07-12 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 .08 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2XLN4Y044H 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 68083-175-01 Regadenoson 5 mL in 1 VIAL INJECTION, SOLUTION 5 5 68083-175-10 Regadenoson 10 in 1 CARTON INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-175 REGADENOSON INJECTION, SOLUTION [GLAND PHARMA LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20220717_5e4109f0-4875-4f8e-b70d-4055b3a785a3.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 Marketing end Sample Exclude flag Status 68083-175-01 68083017501 5 mL in 1 VIAL 5 ml Historical 68083-175-10 68083017510 10 VIAL in 1 CARTON (68083-175-10) / 5 mL in 1 VIAL (68083-175-01) 10 vial 2022-07-12 0000-00-00 No No Current