Home NDC 71335-9610 Digoxin
Product NDC 71335-9610
11-digit product format 713359610
Labeler code 71335
Product ID 71335-9610_612baa66-08c5-4a72-a996-1e310955cfb3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Digoxin
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
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 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 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 2027-12-31 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9610 DIGOXIN TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 7 package rows 20240727_5fb1bc4e-5806-4c50-aab0-91e445d87933.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 71335-9610-1 71335961001 30 TABLET in 1 BOTTLE (71335-9610-1) 30 tablet 2026-04-16 0000-00-00 No No Current 71335-9610-2 71335961002 90 TABLET in 1 BOTTLE (71335-9610-2) 90 tablet 2022-12-19 0000-00-00 No No Current 71335-9610-3 71335961003 15 TABLET in 1 BOTTLE (71335-9610-3) 15 tablet 2026-04-16 0000-00-00 No No Current 71335-9610-4 71335961004 6 TABLET in 1 BOTTLE (71335-9610-4) 6 tablet 2023-09-22 0000-00-00 No No Current 71335-9610-5 71335961005 60 TABLET in 1 BOTTLE (71335-9610-5) 60 tablet 2026-04-16 0000-00-00 No No Current 71335-9610-6 71335961006 100 TABLET in 1 BOTTLE (71335-9610-6) 100 tablet 2026-04-16 0000-00-00 No No Current 71335-9610-7 71335961007 10 TABLET in 1 BOTTLE (71335-9610-7) 10 tablet 2026-04-16 0000-00-00 No No Current