Home NDC 0781-3059 Digoxin
Product NDC 0781-3059
11-digit product format 007813059
Labeler code 0781
Product ID 0781-3059_62ffbb27-b026-4fb2-b2a1-5c170036b8cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Digoxin
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; PARENTERAL
Labeler Sandoz Inc
Application ANDA040481
Marketing category ANDA
Marketing start 2003-08-21
Substance DIGOXIN
Active strength 250 ug/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 A040481-001 DIGOXIN DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040481-001 AP
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 · 42 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 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040481-001 DIGOXIN 0.25MG/ML INJECTABLE / INJECTION AP 2003-08-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 250 ug/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 104208 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 0781-3059-72 Digoxin 2 mL in 1 AMPULE INJECTION, SOLUTION 2 28 0781-3059-95 Digoxin 10 in 1 CARTON INJECTION, SOLUTION 10 28
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3059 DIGOXIN INJECTION, SOLUTION [SANDOZ INC] 27 Current NDC, Legacy NDC, 2 package rows 20241020_58f45aba-ff6f-43cc-bb88-be40a9f7beda.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 0781-3059-72 00781305972 2 mL in 1 AMPULE 2 ml Historical 0781-3059-95 00781305995 10 AMPULE in 1 CARTON (0781-3059-95) / 2 mL in 1 AMPULE (0781-3059-72) 10 ampule 2003-08-21 0000-00-00 No No Current