Home NDC 0404-9993 ADENOSINE
Product NDC 0404-9993
11-digit product format 004049993
Labeler code 0404
Product ID 0404-9993_47940007-a18b-41a8-8aa8-92e28da7545d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name adenosine injection, solution
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA077133
Marketing category ANDA
Marketing start 2023-06-28
Substance ADENOSINE
Active strength 3 mg/mL
Pharmacologic classes Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [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 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 A077133-001 ADENOSINE ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077133-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077133-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2005-04-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ADENOSINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADENOSINE 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K72T3FS567 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1654169 Internal RxNorm 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 0404-9993-02 ADENOSINE 1 in 1 BAG INJECTION, SOLUTION 1 4 0404-9993-02 ADENOSINE 2 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9993 ADENOSINE (ADENOSINE INJECTION, SOLUTION) INJECTION, SOLUTION [HENRY SCHEIN, INC.] 3 Current NDC, 2 package rows 20240120_d28ff4f3-baf4-4640-ae00-f0eb065417be.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ADENOSINE ADENOSINE INJECTION, SOLUTION Henry Schein, Inc. d28ff4f3-baf4-4640-ae00-f0eb065417be 2025-10-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077133 application number: ANDA077133 ndc (product): 0404-9993 ADENOSINE ADENOSINE HF Acquisition Co LLC, DBA HealthFirst 996fc80e-b680-31f1-e053-2995a90aa0f1 2023-12-15 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077133 application number: ANDA077133 ADENOSINE ADENOSINE HF Acquisition Co LLC, DBA HealthFirst fecdce1e-4233-f44c-e053-6294a90a714f 2023-06-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077133 application number: ANDA077133 Adenosine ADENOSINE Fresenius Kabi USA, LLC e660f71c-35ed-438e-8505-4538f5e925a2 2023-04-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077133 application number: ANDA077133
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0404-9993-02 00404999302 1 VIAL, SINGLE-USE in 1 BAG (0404-9993-02) / 2 mL in 1 VIAL, SINGLE-USE 2023-06-28 No No Current