Home NDC 0703-8776-01 Adenosine
Product NDC 0703-8776
Requested package NDC 0703-8776-01
11-digit product format 007038776
Labeler code 0703
Product ID 0703-8776_6e64c28a-1348-431d-a547-1d4d016eb4d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adenosine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA077425
Marketing category ANDA
Marketing start 2013-09-23
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 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A077425-001 ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 A077425-002 ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29
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 · 82 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 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077425-001 ADENOSINE 60MG/20ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077425-002 ADENOSINE 90MG/30ML (3MG/ML) SOLUTION / INTRAVENOUS AP RS 2013-08-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ADENOSINE ACTIVE INGREDIENT K72T3FS567 ADENOSINE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 ADENOSINE ACTIVE MOIETY K72T3FS567 ADENOSINE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ADENOSINE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R ADENOSINE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Adenosine ADENOSINE Meitheal Pharmaceuticals Inc. b6851256-6cef-4f23-8129-19bb64380cd5 2025-04-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077425 application number: ANDA077425
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0703-8776-01 00703877601 1 VIAL, SINGLE-USE in 1 CARTON (0703-8776-01) > 20 mL in 1 VIAL, SINGLE-USE 2013-09-23 0000-00-00 No No Current