Home NDC 63323-651 Adenosine
Product NDC 63323-651
11-digit product format 633230651
Labeler code 63323
Product ID 63323-651_2a538eee-679f-4606-b36f-5fc0fb1c885d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ADENOSINE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA077897
Marketing category ANDA
Marketing start 2017-11-27
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077897-001 ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 A077897-002 ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077897-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077897-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2017-11-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1654035 Internal RxNorm lookup 1654040 Internal RxNorm lookup 1654169 Internal RxNorm lookup 1654186 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 63323-651-00 Adenosine 2 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 2 4 63323-651-01 Adenosine 4 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 4 4 63323-651-02 Adenosine 10 in 1 TRAY INJECTION, SOLUTION 10 4 63323-651-04 Adenosine 10 in 1 TRAY INJECTION, SOLUTION 10 4 63323-651-20 Adenosine 1 in 1 CARTON INJECTION, SOLUTION 1 3 63323-651-20 Adenosine 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 3 63323-651-30 Adenosine 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 3 63323-651-30 Adenosine 1 in 1 CARTON INJECTION, SOLUTION 1 3 63323-651-21 Adenosine 2 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 2 1 63323-651-23 Adenosine 4 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 4 1 63323-651-89 Adenosine 10 in 1 CARTON INJECTION, SOLUTION 10 1 63323-651-90 Adenosine 10 in 1 CARTON INJECTION, SOLUTION 10 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-651 ADENOSINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 4 Current NDC, Legacy NDC, 4 package rows 20230830_e660f71c-35ed-438e-8505-4538f5e925a2.zip 63323-651 ADENOSINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC, 4 package rows 20230406_f88a8cf7-d354-42f2-b5e8-ba002fcfc460.zip 63323-651 ADENOSINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 Current NDC, Legacy NDC, 4 package rows 20190328_6785cf30-360f-409b-a4b2-fc910728f01f.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-651-00 63323065100 2 mL in 1 VIAL, SINGLE-USE 2 ml Historical 63323-651-01 63323065101 4 mL in 1 VIAL, SINGLE-USE 4 ml Historical 63323-651-02 63323065102 10 VIAL, SINGLE-USE in 1 TRAY (63323-651-02) / 2 mL in 1 VIAL, SINGLE-USE (63323-651-00) 2005-11-23 0000-00-00 No No Current 63323-651-04 63323065104 10 VIAL, SINGLE-USE in 1 TRAY (63323-651-04) / 4 mL in 1 VIAL, SINGLE-USE (63323-651-01) 2005-11-23 0000-00-00 No No Current 63323-651-20 63323065120 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-651-20) / 20 mL in 1 VIAL, SINGLE-DOSE 2017-11-27 0000-00-00 No No Current 63323-651-21 63323065121 2 mL in 1 SYRINGE, PLASTIC 2 ml Historical 63323-651-23 63323065123 4 mL in 1 SYRINGE, PLASTIC 4 ml Historical 63323-651-30 63323065130 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-651-30) / 30 mL in 1 VIAL, SINGLE-DOSE 2017-11-27 0000-00-00 No No Current 63323-651-89 63323065189 10 SYRINGE, PLASTIC in 1 CARTON (63323-651-89) / 2 mL in 1 SYRINGE, PLASTIC (63323-651-21) 2018-04-16 0000-00-00 No No Current 63323-651-90 63323065190 10 SYRINGE, PLASTIC in 1 CARTON (63323-651-90) / 4 mL in 1 SYRINGE, PLASTIC (63323-651-23) 2018-04-16 0000-00-00 No No Current