Home NDC 0904-5922 Digoxin
Product NDC 0904-5922
11-digit product format 009045922
Labeler code 0904
Product ID 0904-5922_fad1e8b6-cb2e-46de-8f64-22de878e8028
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Digoxin
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA077002
Marketing category ANDA
Marketing start 2009-06-10
Substance DIGOXIN
Active strength 250 ug/1
Pharmacologic classes Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A077002-001 DIGOXIN DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 A077002-002 DIGOXIN DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30
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 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077002-001 DIGOXIN 0.25MG TABLET / ORAL AB 2007-10-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077002-002 DIGOXIN 0.125MG TABLET / ORAL AB 2007-10-30 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 Digoxin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIGOXIN 250 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 73K4184T59 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197604 Internal RxNorm lookup 197606 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 0904-5922-61 Digoxin 100 in 1 CARTON TABLET 100 14 0904-5922-61 Digoxin 1 in 1 BLISTER PACK TABLET 1 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-5922 DIGOXIN TABLET [MAJOR PHARMACEUTICALS] 12 Current NDC, Legacy NDC, 2 package rows 20241212_48cad559-c17b-4d41-a154-e664e958c1c0.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Digoxin DIGOXIN NCS HealthCare of KY, LLC dba Vangard Labs 5886e233-b2da-4acb-be05-9bf40fb8e7f4 2026-07-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077002 application number: ANDA077002 Digoxin DIGOXIN Golden State Medical Supply, Inc. 2636527a-1ecd-455f-a928-19549ac83fa1 2026-04-14 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077002 application number: ANDA077002 Digoxin DIGOXIN Cardinal Health 107, LLC 51925501-ab5b-4e12-a67e-ec2b4b592e83 2026-03-20 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077002 application number: ANDA077002 Digoxin DIGOXIN Major Pharmaceuticals 48cad559-c17b-4d41-a154-e664e958c1c0 2026-03-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077002 application number: ANDA077002 ndc (product): 0904-5922 Digoxin DIGOXIN Hikma Pharmaceuticals USA Inc. 41c16cff-b03e-405e-a617-d6f45d3ce2bd 2024-06-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077002 application number: ANDA077002
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 0904-5922-60 00904592260 100 TABLET in 1 BOTTLE (0904-5922-60) 100 tablet 2009-06-10 2021-07-31 No No Current 0904-5922-61 00904592261 100 BLISTER PACK in 1 CARTON (0904-5922-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2009-06-10 0000-00-00 No No Current 0904-5922-80 00904592280 1000 TABLET in 1 BOTTLE (0904-5922-80) 1000 tablet 2009-06-10 0000-00-00 No No Current