Home NDC 70954-202 Digoxin
Product NDC 70954-202
11-digit product format 709540202
Labeler code 70954
Product ID 70954-202_ee465d1a-f5ee-477b-b20e-3ce8705e7472
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Digoxin
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA215307
Marketing category ANDA
Marketing start 2021-11-22
Substance DIGOXIN
Active strength .25 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 1 .
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 · 93 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 2026-02-19 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215307-002 DIGOXIN 0.25MG TABLET / ORAL AB 2021-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215307-003 DIGOXIN 0.0625MG TABLET / ORAL AB 2022-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215307-001 DIGOXIN 0.125MG TABLET / ORAL AB 2021-11-22 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 93 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 .25 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197604 Internal RxNorm lookup 197606 Internal RxNorm lookup 245273 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 70954-202-10 Digoxin 100 in 1 BOTTLE TABLET 100 4 70954-202-20 Digoxin 1000 in 1 BOTTLE TABLET 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-202 DIGOXIN TABLET [ANI PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240511_dba3b3f7-3ff2-4996-8653-b0e54a398bf9.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 70954-202-10 70954020210 100 TABLET in 1 BOTTLE (70954-202-10) 100 tablet 2021-11-22 0000-00-00 No No Current 70954-202-20 70954020220 1000 TABLET in 1 BOTTLE (70954-202-20) 1000 tablet 2021-11-22 0000-00-00 No No Current