Digoxin

Product NDC: 84549-410
11-digit product format: 845490410
Labeler code: 84549
Product ID: 84549-410_45b0d1e0-d1f5-28f6-e063-6394a90aaa51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Digoxin
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: ProPharma Distribution
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: 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
A083391-001	DIGOXIN	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A083391-001	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	Source SHA-256
2026-08-18 06:07:40	2026-07	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083391-001	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A083391-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083391-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083391-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083391-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083391-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083391-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083391-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083391-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083391-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083391-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083391-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083391-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083391-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083391-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083391-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083391-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083391-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083391-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083391-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083391-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083391-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083391-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083391-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083391-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083391-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083391-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083391-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083391-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083391-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083391-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083391-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083391-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083391-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083391-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083391-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083391-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083391-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083391-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083391-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083391-001	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIGOXIN	.25 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
104208	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
45b0d1e0-d1f6-28f6-e063-6394a90aaa51	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
20d84de3-cb46-44c4-9211-63e833fa2688	Product name	2	20221214
4d74103a-bb9b-9034-fbc8-dac635e6e729	Product name	3	20221117
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5c3aa978-6f46-c7ca-2a83-b57385976bee	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84549-410-35	Digoxin	2 mL in 1 AMPULE	INJECTION	2		1

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIGOXIN	DIGOXIN	HF Acquisition Co LLC, DBA HealthFirst	75c99fc4-33b6-c3ce-e053-2991aa0a4d88	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391
Digoxin	DIGOXIN	Cardinal Health 107, LLC	6aba2b38-5de0-4813-9775-39d87613893d	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391
Digoxin	DIGOXIN	Henry Schein, Inc.	98d2ad5b-9ffa-4456-9a01-567636c3a4d2	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	9b9a4b3c-5f08-475a-a74d-0c7ebba40644	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391
Digoxin	DIGOXIN	ProPharma Distribution	45b0d1e0-d1f6-28f6-e063-6394a90aaa51	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391 ndc (product): 84549-410
Digoxin	DIGOXIN	Hikma Pharmaceuticals USA Inc.	3933b07f-5857-4a80-b502-e3214bdf9330	2025-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083391 application number: ANDA083391

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
73K4184T59	DIGOXIN	20830-75-5	DIGOXIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
104208	digoxin 500 MCG in 2 ML Injection	PSN	45b0d1e0-d1f6-28f6-e063-6394a90aaa51	1
104208	2 ML digoxin 0.25 MG/ML Injection	SCD	45b0d1e0-d1f6-28f6-e063-6394a90aaa51	1
104208	digoxin 500 MCG per 2 ML Injection	SY	45b0d1e0-d1f6-28f6-e063-6394a90aaa51	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-410-35	84549041035	2 mL in 1 AMPULE (84549-410-35)	2 ml	2025-12-11	No	No	Current