Home NDC 17478-544 Adenosine
Product NDC 17478-544
11-digit product format 174780544
Labeler code 17478
Product ID 17478-544_b1fc905c-f8df-44b7-a194-0d5ef762c7fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adenosine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Akorn
Application ANDA090450
Marketing category ANDA
Marketing start 2014-10-02
Marketing end 0000-00-00
Substance ADENOSINE
Active strength 3 mg/mL
Pharmacologic classes Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A090450-001 ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 A090450-002 ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02
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 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090450-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090450-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-02 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Adenosine ACTIVE INGREDIENT K72T3FS567 ADENOSINE INJECTION, SOLUTION [AKORN, INC.] 4 Adenosine ACTIVE MOIETY K72T3FS567 ADENOSINE INJECTION, SOLUTION [AKORN, INC.] 4 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X ADENOSINE INJECTION, SOLUTION [AKORN, INC.] 4 Water INACTIVE INGREDIENT 059QF0KO0R ADENOSINE INJECTION, SOLUTION [AKORN, INC.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17478-544-20 17478054420 1 VIAL in 1 CARTON (17478-544-20) > 20 mL in 1 VIAL 1 vial 2014-10-02 0000-00-00 No No Current 17478-544-30 17478054430 1 VIAL in 1 CARTON (17478-544-30) > 30 mL in 1 VIAL 1 vial 2014-10-02 0000-00-00 No No Current