Home NDC 66689-327 Digoxin
Product NDC 66689-327
11-digit product format 666890327
Labeler code 66689
Product ID 66689-327_217566e2-b3e4-4c7b-9ff6-d1088df1526a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Digoxin
Dosage form SOLUTION
Route ORAL
Labeler VistaPharm, LLC
Application ANDA213000
Marketing category ANDA
Marketing start 2019-10-04
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 42 .
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 A213000-001 DIGOXIN DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213000-001 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 2026-08-18 06:07:40 2026-07 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213000-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA 2019-10-04 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 A213000-001 CGT 2020-04-01 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 A213000-001 CGT 2020-04-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213000-001 CGT 2020-04-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A213000-001 CGT 2020-04-01 3f01610625f2…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66689-327-02 Digoxin 60 mL in 1 BOTTLE, GLASS SOLUTION 60 11 66689-327-02 Digoxin 1 in 1 CARTON SOLUTION 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66689-327 DIGOXIN SOLUTION [VISTAPHARM, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20240730_ce62a741-a981-4880-8ce3-93269606a730.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 Marketing start Marketing end Sample Exclude flag Status 66689-327-02 66689032702 1 BOTTLE, GLASS in 1 CARTON (66689-327-02) / 60 mL in 1 BOTTLE, GLASS 2019-10-04 0000-00-00 No No Current