Digoxin

Product NDC
0641-1410
11-digit product format
006411410
Labeler code
0641
Product ID
0641-1410_135cf10d-a417-45fa-a169-85a8bcec0bd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Digoxin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA083391
Marketing category
ANDA
Marketing start
1975-10-24
Substance
DIGOXIN
Active strength
.25 mg/mL
Pharmacologic classes
Cardiac Glycoside [EPC], Cardiac Glycosides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A083391-001DIGOXINDIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A083391-001AP

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 06:07:402026-07A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A083391-001DIGOXIN0.25MG/MLINJECTABLE / INJECTIONAPApproved before 1982e64feba35796…

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 06:07:402026-07A083391-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A083391-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083391-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A083391-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083391-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083391-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083391-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083391-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083391-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083391-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083391-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083391-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083391-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083391-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083391-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083391-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083391-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083391-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083391-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083391-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083391-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083391-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A083391-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083391-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083391-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083391-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A083391-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A083391-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A083391-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A083391-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A083391-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A083391-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A083391-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A083391-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A083391-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A083391-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A083391-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A083391-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A083391-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A083391-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Digoxin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIGOXIN.25 mg/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
3933b07f-5857-4a80-b502-e3214bdf9330Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5c3aa978-6f46-c7ca-2a83-b57385976beeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-1410-31Digoxin2 mL in 1 AMPULEINJECTION225
0641-1410-35Digoxin25 in 1 CARTONINJECTION2525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-1410-31ML - Milliliter0641-14100f2f1428-8112-487f-aa27-07b325ac601912012-07-24
0641-1410-35ML - Milliliter0641-141081e89f85-4425-489d-acdf-b16ee1d1882a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIGOXINACTIVE INGREDIENT73K4184T59DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
DIGOXINACTIVE MOIETY73K4184T59DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37DIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
WATERINACTIVE INGREDIENT059QF0KO0RDIGOXIN INJECTION [WEST-WARD PHARMACEUTICALS CORP.]16
digoxinACTIVE INGREDIENT73K4184T59DIGOXIN INJECTION [CARDINAL HEALTH]6
digoxinACTIVE MOIETY73K4184T59DIGOXIN INJECTION [CARDINAL HEALTH]6
alcoholINACTIVE INGREDIENT3K9958V90MDIGOXIN INJECTION [CARDINAL HEALTH]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIGOXIN INJECTION [CARDINAL HEALTH]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDIGOXIN INJECTION [CARDINAL HEALTH]6
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DIGOXIN INJECTION [CARDINAL HEALTH]6
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY37DIGOXIN INJECTION [CARDINAL HEALTH]6
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FDIGOXIN INJECTION [CARDINAL HEALTH]6
waterINACTIVE INGREDIENT059QF0KO0RDIGOXIN INJECTION [CARDINAL HEALTH]6
DigoxinACTIVE INGREDIENT73K4184T59DIGOXIN INJECTION [GENERAL INJECATABLES & VACCINES, INC]4
DigoxinACTIVE MOIETY73K4184T59DIGOXIN INJECTION [GENERAL INJECATABLES & VACCINES, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-1410DIGOXIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]24Current NDC, Legacy NDC, 2 package rows20250213_3933b07f-5857-4a80-b502-e3214bdf9330.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIGOXINDIGOXINHF Acquisition Co LLC, DBA HealthFirst75c99fc4-33b6-c3ce-e053-2991aa0a4d882026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083391
application number: ANDA083391
DigoxinDIGOXINCardinal Health 107, LLC6aba2b38-5de0-4813-9775-39d87613893d2026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083391
application number: ANDA083391
DigoxinDIGOXINHenry Schein, Inc.98d2ad5b-9ffa-4456-9a01-567636c3a4d22026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083391
application number: ANDA083391
DigoxinDIGOXINHikma Pharmaceuticals USA Inc.9b9a4b3c-5f08-475a-a74d-0c7ebba406442026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083391
application number: ANDA083391
DigoxinDIGOXINProPharma Distribution45b0d1e0-d1f6-28f6-e063-6394a90aaa512025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083391
application number: ANDA083391
DigoxinDIGOXINHikma Pharmaceuticals USA Inc.3933b07f-5857-4a80-b502-e3214bdf93302025-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083391
application number: ANDA083391
ndc (product): 0641-1410

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104208digoxin 500 MCG in 2 ML InjectionPSN3933b07f-5857-4a80-b502-e3214bdf933025
1042082 ML digoxin 0.25 MG/ML InjectionSCD3933b07f-5857-4a80-b502-e3214bdf933025
104208digoxin 500 MCG per 2 ML InjectionSY3933b07f-5857-4a80-b502-e3214bdf933025
104208digoxin 500 MCG in 2 ML InjectionPSN6aba2b38-5de0-4813-9775-39d87613893d15
1042082 ML digoxin 0.25 MG/ML InjectionSCD6aba2b38-5de0-4813-9775-39d87613893d15
104208digoxin 500 MCG per 2 ML InjectionSY6aba2b38-5de0-4813-9775-39d87613893d15
104208digoxin 500 MCG in 2 ML InjectionPSN75c99fc4-33b6-c3ce-e053-2991aa0a4d887
104208digoxin 500 MCG in 2 ML InjectionPSN98d2ad5b-9ffa-4456-9a01-567636c3a4d27
1042082 ML digoxin 0.25 MG/ML InjectionSCD75c99fc4-33b6-c3ce-e053-2991aa0a4d887
1042082 ML digoxin 0.25 MG/ML InjectionSCD98d2ad5b-9ffa-4456-9a01-567636c3a4d27
104208digoxin 500 MCG per 2 ML InjectionSY75c99fc4-33b6-c3ce-e053-2991aa0a4d887
104208digoxin 500 MCG per 2 ML InjectionSY98d2ad5b-9ffa-4456-9a01-567636c3a4d27
104208digoxin 500 MCG in 2 ML InjectionPSN45b0d1e0-d1f6-28f6-e063-6394a90aaa511
1042082 ML digoxin 0.25 MG/ML InjectionSCD45b0d1e0-d1f6-28f6-e063-6394a90aaa511
104208digoxin 500 MCG per 2 ML InjectionSY45b0d1e0-d1f6-28f6-e063-6394a90aaa511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-1410-31006411410312 mL in 1 AMPULE2 mlHistorical
0641-1410-350064114103525 AMPULE in 1 CARTON (0641-1410-35) / 2 mL in 1 AMPULE (0641-1410-31) 25 ampule1975-10-240000-00-00NoNoCurrent