LANOXIN

Product NDC: 70515-263
11-digit product format: 705150263
Labeler code: 70515
Product ID: 70515-263_415f97e2-9ce0-b282-e063-6394a90ab0a8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: digoxin
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Covis Pharma US, Inc
Application: NDA009330
Marketing category: NDA
Marketing start: 2019-10-29
Substance: DIGOXIN
Active strength: 100 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N009330-002	LANOXIN	DIGOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N009330-004	LANOXIN PEDIATRIC	DIGOXIN	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, 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
N009330-002	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 3 · 84 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	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009330-002	LANOXIN	0.25MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N009330-004	LANOXIN PEDIATRIC	0.1MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`bb7c543d1eb4…`

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	N009330-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009330-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009330-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009330-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009330-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009330-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009330-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009330-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009330-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009330-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009330-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009330-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009330-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009330-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N009330-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N009330-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N009330-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N009330-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N009330-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009330-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009330-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009330-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009330-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009330-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009330-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009330-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009330-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009330-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009330-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009330-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009330-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009330-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009330-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009330-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009330-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009330-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009330-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009330-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N009330-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N009330-002	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIGOXIN	100 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
104208	Internal RxNorm lookup
204504	Internal RxNorm lookup
208135	Internal RxNorm lookup
208137	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
9ec84cac-6ecc-43dc-8006-6ccc029e2707	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
20d84de3-cb46-44c4-9211-63e833fa2688	Product name	2	20221214
4d74103a-bb9b-9034-fbc8-dac635e6e729	Product name	3	20221117
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
70515-263-10	LANOXIN	1 mL in 1 VIAL	INJECTION, SOLUTION	1		10
70515-263-10	LANOXIN	10 in 1 BOX	INJECTION, SOLUTION	10		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70515-263-10	ML - Milliliter	70515-263	f5bcd3cc-c684-42c7-b334-d367710a3f99	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70515-263	LANOXIN (DIGOXIN) INJECTION, SOLUTION [COVIS PHARMA US, INC]	9	Current NDC, Legacy NDC, 2 package rows	20250115_9ec84cac-6ecc-43dc-8006-6ccc029e2707.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LANOXIN	DIGOXIN	Covis Pharma US, Inc	9ec84cac-6ecc-43dc-8006-6ccc029e2707	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009330 application number: NDA009330 ndc (product): 70515-263

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
204504	digoxin 100 MCG in 1 ML Injection	PSN	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
104208	digoxin 500 MCG in 2 ML Injection	PSN	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
208137	LANOXIN 500 MCG in 2 ML Injection	PSN	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
208135	LANOXIN Pediatric 100 MCG in 1 ML Injection	PSN	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
208135	1 ML digoxin 0.1 MG/ML Injection [Lanoxin]	SBD	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
208137	2 ML digoxin 0.25 MG/ML Injection [Lanoxin]	SBD	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
204504	1 ML digoxin 0.1 MG/ML Injection	SCD	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
104208	2 ML digoxin 0.25 MG/ML Injection	SCD	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
204504	digoxin 100 MCG per 1 ML Injection	SY	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
104208	digoxin 500 MCG per 2 ML Injection	SY	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
208135	Lanoxin 100 MCG per 1 ML Injection	SY	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10
208137	Lanoxin 500 MCG per 2 ML Injection	SY	9ec84cac-6ecc-43dc-8006-6ccc029e2707	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70515-263-10	70515026310	10 VIAL in 1 BOX (70515-263-10) / 1 mL in 1 VIAL	10 vial	2019-10-29	0000-00-00	No	No	Current