Home NDC 68083-101 Adenosine
Product NDC 68083-101
11-digit product format 680830101
Labeler code 68083
Product ID 68083-101_e47b17c4-e913-43cf-8406-c38e16f5ae36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adenosine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA077283
Marketing category ANDA
Marketing start 2013-04-01
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 A077283-001 ADENOSINE ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077283-001 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 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077283-001 ADENOSINE 3MG/ML INJECTABLE / INJECTION AP 2007-06-14 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 727355 Internal RxNorm lookup 727360 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 68083-101-01 Adenosine 10 in 1 CARTON INJECTION 10 3 68083-101-01 Adenosine 2 mL in 1 SYRINGE INJECTION 2 3 68083-101-02 Adenosine 10 in 1 CARTON INJECTION 10 3 68083-101-02 Adenosine 4 mL in 1 SYRINGE INJECTION 4 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-101 ADENOSINE INJECTION [GLAND PHARMA LIMITED] 3 Current NDC, Legacy NDC, 4 package rows 20171209_ab2edabd-e57d-4754-9822-93bd17af9e88.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.
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 68083-101-01 68083010101 10 SYRINGE in 1 CARTON (68083-101-01) / 2 mL in 1 SYRINGE 10 syringe 2013-04-01 0000-00-00 No No Current 68083-101-02 68083010102 10 SYRINGE in 1 CARTON (68083-101-02) / 4 mL in 1 SYRINGE 10 syringe 2013-04-01 0000-00-00 No No Current