Home NDC 10135-803 Regadenoson
Product NDC 10135-803
11-digit product format 101350803
Labeler code 10135
Product ID 10135-803_b35f97f9-3052-4431-893e-ec9218aab105
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Regadenoson
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA218054
Marketing category ANDA
Marketing start 2024-08-22
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 A218054-001 REGADENOSON REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218054-001 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 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218054-001 REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP 2024-08-22 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 10135-803-51 Regadenoson 5 mL in 1 SYRINGE INJECTION, SOLUTION 5 1 10135-803-51 Regadenoson 1 in 1 CARTON INJECTION, SOLUTION 1 1
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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10135-803-51 10135080351 1 SYRINGE in 1 CARTON (10135-803-51) / 5 mL in 1 SYRINGE 1 syringe 2024-08-22 No No Current