Home NDC 60687-858 Digoxin
Product NDC 60687-858
11-digit product format 606870858
Labeler code 60687
Product ID 60687-858_31b908f2-f5f7-176f-e063-6294a90a0bf1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Digoxin
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA215307
Marketing category ANDA
Marketing start 2025-02-06
Substance DIGOXIN
Active strength .125 mg/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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215307-001 DIGOXIN DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 A215307-002 DIGOXIN DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 A215307-003 DIGOXIN DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 96 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 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 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 mg/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 60687-858-01 Digoxin 100 in 1 CARTON TABLET 100 3 60687-858-11 Digoxin 1 in 1 BLISTER PACK TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-858 DIGOXIN TABLET [AMERICAN HEALTH PACKAGING] 3 Current NDC, 2 package rows 20250403_5500ee2a-077d-486c-b56d-36e0c5e5c31d.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 Sample Exclude flag Status 60687-858-01 60687085801 100 BLISTER PACK in 1 CARTON (60687-858-01) / 1 TABLET in 1 BLISTER PACK (60687-858-11) 100 blister pack 2025-02-06 No No Current 60687-858-11 60687085811 1 in 1 BLISTER PACK Historical