Home NDC 0054-0057 Digoxin
Product NDC 0054-0057
11-digit product format 000540057
Labeler code 0054
Product ID 0054-0057_db501397-8e41-4498-8626-49c6bfd79971
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Digoxin
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA021648
Marketing category NDA
Marketing start 2004-08-26
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 N021648-001 DIGOXIN DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021648-001 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.
Product history page 1 of 2 · 41 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 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL RLD, RS 2004-08-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL RLD, RS 2004-08-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021648-001 DIGOXIN 0.05MG/ML ELIXIR / ORAL AA RLD, RS 2004-08-26 cb3db0bc1861…
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 0054-0057-46 Digoxin 60 mL in 1 BOTTLE SOLUTION 60 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIGOXIN ACTIVE INGREDIENT 73K4184T59 DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 DIGOXIN ACTIVE MOIETY 73K4184T59 DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 LIME (CITRUS) INACTIVE INGREDIENT 8CZS546954 DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 SORBITOL INACTIVE INGREDIENT 506T60A25R DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 WATER INACTIVE INGREDIENT 059QF0KO0R DIGOXIN SOLUTION [ROXANE LABORATORIES, INC] 10 DIGOXIN ACTIVE INGREDIENT 73K4184T59 DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6 DIGOXIN ACTIVE MOIETY 73K4184T59 DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6 LIME (CITRUS) INACTIVE INGREDIENT 8CZS546954 DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6 WATER INACTIVE INGREDIENT 059QF0KO0R DIGOXIN SOLUTION [ATLANTIC BIOLOGICALS CORPS] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0057 DIGOXIN SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 18 Current NDC, Legacy NDC, 1 package rows 20250418_1b7e5c6e-e052-41b0-a4ce-05dfe62faaaf.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 · 2 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 0054-0057-46 00054005746 60 mL in 1 BOTTLE (0054-0057-46) 60 ml 2004-08-26 0000-00-00 No No Current