Digoxin

Product NDC
71872-7325
11-digit product format
718727325
Labeler code
71872
Product ID
71872-7325_28f36bb9-d1ee-b548-e063-6394a90ae8ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; PARENTERAL
Labeler
Medical Purchasing Solutions, LLC
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040481-001DIGOXINDIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040481-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-213f01610625f2…
2019-09-15 20:21 UTC2019-09A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040481-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAP2003-08-21e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040481-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040481-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040481-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040481-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040481-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040481-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040481-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040481-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040481-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040481-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040481-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040481-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040481-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040481-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040481-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040481-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040481-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040481-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040481-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040481-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040481-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040481-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040481-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040481-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040481-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040481-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040481-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040481-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040481-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040481-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040481-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040481-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040481-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040481-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040481-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040481-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040481-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040481-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040481-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040481-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Digoxin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIGOXIN250 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
73K4184T59Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
104208Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
28f2c2cd-e58c-aea2-e063-6394a90a73e7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
20d84de3-cb46-44c4-9211-63e833fa2688Product name220221214
4d74103a-bb9b-9034-fbc8-dac635e6e729Product name320221117
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
5c3aa978-6f46-c7ca-2a83-b57385976beeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7325-1Digoxin1 in 1 BAGINJECTION, SOLUTION11
71872-7325-1Digoxin2 mL in 1 AMPULEINJECTION, SOLUTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7325DIGOXIN INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]1Current NDC, 2 package rows20241212_28f2c2cd-e58c-aea2-e063-6394a90a73e7.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DigoxinDIGOXINSandoz Inc58f45aba-ff6f-43cc-bb88-be40a9f7beda2025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040481
application number: ANDA040481
DigoxinDIGOXINMedical Purchasing Solutions, LLC28f2c2cd-e58c-aea2-e063-6394a90a73e72024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040481
application number: ANDA040481
ndc (product): 71872-7325

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104208digoxin 500 MCG in 2 ML InjectionPSN28f2c2cd-e58c-aea2-e063-6394a90a73e71
1042082 ML digoxin 0.25 MG/ML InjectionSCD28f2c2cd-e58c-aea2-e063-6394a90a73e71
104208digoxin 500 MCG per 2 ML InjectionSY28f2c2cd-e58c-aea2-e063-6394a90a73e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71872-7325-1718727325011 AMPULE in 1 BAG (71872-7325-1) / 2 mL in 1 AMPULE1 ampule2024-05-29NoNoCurrent