Home NDC 71335-1052 Digoxin
Product NDC 71335-1052
11-digit product format 713351052
Labeler code 71335
Product ID 71335-1052_da4dc6d4-362b-4e3b-9106-446c32dd1a02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIGOXIN
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078556
Marketing category ANDA
Marketing start 2009-07-20
Marketing end 0000-00-00
Substance DIGOXIN
Active strength 125 ug/1
Pharmacologic classes Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
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 2 · 120 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 A078556-001 DIGOXIN DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 A078556-002 DIGOXIN DIGOXIN 0.25MG TABLET / ORAL 2009-07-20
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 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078556-001 DIGOXIN 0.125MG TABLET / ORAL 2009-07-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078556-002 DIGOXIN 0.25MG TABLET / ORAL 2009-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078556-001 DIGOXIN 0.125MG TABLET / ORAL AB 2009-07-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078556-002 DIGOXIN 0.25MG TABLET / ORAL AB 2009-07-20 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-1052-1 2024-10-23 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-2 2024-10-23 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-3 2024-10-23 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-4 2024-10-23 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-5 2024-10-23 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-6 2024-10-23 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-7 2024-10-23 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-1 2024-01-30 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-2 2024-01-30 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-3 2024-01-30 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-4 2024-01-30 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-5 2024-01-30 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-6 2024-01-30 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954 71335-1052-7 2024-01-30 These highlights do not include all the information needed to use DIGOXIN TABLETS safely and effectively. See full prescribing information for DIGOXIN TABLETS. DIGOXIN tablets, for oral use Initial U.S. Approval: 1954
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 Digoxin DIGOXIN Amneal Pharmaceuticals of New York LLC dfac7f13-28be-423d-9389-9089da29da17 2026-01-13 Warnings, Adverse reactions Exact identifier application applno (ANDA): 078556 application number: ANDA078556
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71335-1052-1 71335105201 30 TABLET in 1 BOTTLE (71335-1052-1) 30 tablet 2019-01-10 0000-00-00 No No Current 71335-1052-2 71335105202 90 TABLET in 1 BOTTLE (71335-1052-2) 90 tablet 2019-01-10 0000-00-00 No No Current 71335-1052-3 71335105203 15 TABLET in 1 BOTTLE (71335-1052-3) 15 tablet 2019-01-10 0000-00-00 No No Current 71335-1052-4 71335105204 6 TABLET in 1 BOTTLE (71335-1052-4) 6 tablet 2019-01-10 0000-00-00 No No Current 71335-1052-5 71335105205 60 TABLET in 1 BOTTLE (71335-1052-5) 60 tablet 2019-01-10 0000-00-00 No No Current 71335-1052-6 71335105206 100 TABLET in 1 BOTTLE (71335-1052-6) 100 tablet 2019-01-10 0000-00-00 No No Current 71335-1052-7 71335105207 10 TABLET in 1 BOTTLE (71335-1052-7) 10 tablet 2021-12-28 0000-00-00 No No Current