DISOPYRAMIDE PHOSPHATE

Product NDC: 51862-095
11-digit product format: 518620095
Labeler code: 51862
Product ID: 51862-095_3dfeb589-b234-6c61-e063-6294a90a1deb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DISOPYRAMIDE PHOSPHATE
Dosage form: CAPSULE
Route: ORAL
Labeler: Mayne Pharma Commercial LLC
Application: ANDA070173
Marketing category: ANDA
Marketing start: 2022-04-01
Substance: DISOPYRAMIDE PHOSPHATE
Active strength: 100 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51862-095		D	Discontinued by firm		2026-08-03
excluded package	package	51862-095	51862-095-01	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A070173-001	DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB		1985-05-31
A070173-002	DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB		1985-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A070173-001	AB
A070173-002	AB

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	1985-05-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	1985-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL		1985-05-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL		1985-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070173-001	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL		1985-05-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A070173-002	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL		1985-05-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070173-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070173-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070173-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070173-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070173-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070173-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070173-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070173-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070173-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070173-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070173-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070173-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070173-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070173-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070173-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070173-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070173-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070173-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070173-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070173-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070173-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070173-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070173-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070173-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070173-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070173-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070173-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070173-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070173-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070173-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070173-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070173-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070173-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070173-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070173-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070173-002	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A070173-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A070173-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070173-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A070173-002	AB	1	`8869cabd3fbd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d08b5e1c-4339-4b83-bd26-a59d84e2a782	Product name	1	20170614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51862-095-01	DISOPYRAMIDE PHOSPHATE	100 in 1 BOTTLE	CAPSULE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-095-01	EA - Each	51862-095	9a21ef46-f989-448f-a3b6-87bde12dee22	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-095	DISOPYRAMIDE PHOSPHATE CAPSULE [MAYNE PHARMA COMMERCIAL LLC]	5	Current NDC, Legacy NDC, 1 package rows	20230707_7d550b12-065a-416c-93fa-b61368eeb36f.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
DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE	Dr. Reddy's Labratories Inc.	3acbcef2-04ec-1ab1-b855-d1244b0e8006	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070173 application number: ANDA070173

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N6BOM1935W	DISOPYRAMIDE PHOSPHATE	22059-60-5	DISOPYRAMIDE PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309958	disopyramide phosphate 100 MG Oral Capsule	PSN	7d550b12-065a-416c-93fa-b61368eeb36f	6
309960	disopyramide phosphate 150 MG Oral Capsule	PSN	7d550b12-065a-416c-93fa-b61368eeb36f	6
309958	disopyramide 100 MG Oral Capsule	SCD	7d550b12-065a-416c-93fa-b61368eeb36f	6
309960	disopyramide 150 MG Oral Capsule	SCD	7d550b12-065a-416c-93fa-b61368eeb36f	6
309958	disopyramide 100 MG (as disopyramide phosphate) Oral Capsule	SY	7d550b12-065a-416c-93fa-b61368eeb36f	6
309960	disopyramide 150 MG (as disopyramide phosphate) Oral Capsule	SY	7d550b12-065a-416c-93fa-b61368eeb36f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-095-01	51862009501	100 CAPSULE in 1 BOTTLE (51862-095-01)	100 capsule	2022-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DISOPYRAMIDE PHOSPHATE CAPSULES, USP	Mayne Pharma Commercial LLC \| Catalent Greenville, Inc.	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	6
DISOPYRAMIDE PHOSPHATE CAPSULES, USP	Golden State Medical Supply Inc.	2018-11-20	HUMAN PRESCRIPTION DRUG LABEL	3