Home NDC 69292-605 Digoxin
Product NDC 69292-605
11-digit product format 692920605
Labeler code 69292
Product ID 69292-605_6ea84176-ac4e-47c6-b65c-c203e6e8de98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Digoxin
Dosage form SOLUTION
Route ORAL
Labeler Amici Pharma, Inc
Application ANDA215209
Marketing category ANDA
Marketing start 2022-06-10
Substance DIGOXIN
Active strength .05 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215209-001 DIGOXIN DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215209-001 AA
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.
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 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215209-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2022-03-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Digoxin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIGOXIN .05 mg/mL
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 393245 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 69292-605-60 Digoxin 1 in 1 CARTON SOLUTION 1 6 69292-605-60 Digoxin 60 mL in 1 BOTTLE SOLUTION 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69292-605 DIGOXIN SOLUTION [AMICI PHARMA, INC] 5 Current NDC, Legacy NDC, 2 package rows 20250402_eda7193a-e139-41d5-a11b-dc6241645995.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 · 1 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 69292-605-60 69292060560 1 BOTTLE in 1 CARTON (69292-605-60) / 60 mL in 1 BOTTLE 1 bottle 2022-06-10 0000-00-00 No No Current