Home NDC 50090-5642 Digoxin
Product NDC 50090-5642
11-digit product format 500905642
Labeler code 50090
Product ID 50090-5642_0f092467-7f66-1cb2-e063-6394a90a88a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Digoxin
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA076363
Marketing category ANDA
Marketing start 2015-02-17
Substance DIGOXIN
Active strength 125 ug/1
Pharmacologic classes Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
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 A076363-001 DIGOXIN DIGOXIN 0.125MG TABLET / ORAL 2003-01-31 A076363-002 DIGOXIN DIGOXIN 0.25MG TABLET / ORAL 2003-01-31
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 A076363-001 DIGOXIN 0.125MG TABLET / ORAL 2003-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076363-002 DIGOXIN 0.25MG TABLET / ORAL 2003-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076363-001 DIGOXIN 0.125MG TABLET / ORAL AB 2003-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076363-002 DIGOXIN 0.25MG TABLET / ORAL AB 2003-01-31 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Digoxin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIGOXIN 125 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197604 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 50090-5642-1 Digoxin 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5642 DIGOXIN TABLET [A-S MEDICATION SOLUTIONS] 4 Current NDC, Legacy NDC, 1 package rows 20240117_3d6afb9e-0c6c-40e1-ae26-6e544564ba44.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 50090-5642-1 50090564201 100 TABLET in 1 BOTTLE (50090-5642-1) 100 tablet 2021-09-10 0000-00-00 No No Current