Disopyramide Phosphate

Product NDC: 59762-0386
11-digit product format: 597620386
Labeler code: 59762
Product ID: 59762-0386_ea995a2c-b191-47d5-b4d8-863782880b38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: disopyramide phosphate
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: NDA017447
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-04-23
Substance: DISOPYRAMIDE PHOSPHATE
Active strength: 100 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
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 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
N017447-001	NORPACE	DISOPYRAMIDE PHOSPHATE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017447-002	NORPACE	DISOPYRAMIDE PHOSPHATE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017447-001	AB
N017447-002	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017447-001	NORPACE	EQ 100MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017447-002	NORPACE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N017447-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017447-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017447-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017447-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017447-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017447-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017447-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017447-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017447-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017447-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017447-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017447-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017447-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017447-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017447-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017447-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017447-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017447-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017447-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017447-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017447-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017447-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017447-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017447-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017447-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017447-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017447-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017447-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017447-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017447-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017447-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017447-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017447-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017447-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017447-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017447-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017447-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017447-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017447-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017447-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Disopyramide Phosphate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DISOPYRAMIDE PHOSPHATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N6BOM1935W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309958	Internal RxNorm lookup
309960	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
31e79459-107f-4d69-a163-90014f1c4772	Available on FDA.report

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
59762-0386-1	Disopyramide Phosphate	100 in 1 BOTTLE	CAPSULE, GELATIN COATED	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-0386-1	EA - Each	59762-0386	ecfb6aa4-7310-4b09-9aa1-4ca0205932da	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-0386	DISOPYRAMIDE PHOSPHATE CAPSULE, GELATIN COATED [MYLAN PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250524_31e79459-107f-4d69-a163-90014f1c4772.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norpace CR	DISOPYRAMIDE PHOSPHATE	Pfizer Laboratories Div Pfizer Inc	e2aa1642-d262-4520-bc6a-9fd3ad795677	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017447 application number: NDA017447
Disopyramide Phosphate	DISOPYRAMIDE PHOSPHATE	Mylan Pharmaceuticals Inc.	31e79459-107f-4d69-a163-90014f1c4772	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017447 application number: NDA017447 ndc (product): 59762-0386

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	31e79459-107f-4d69-a163-90014f1c4772	5
309960	disopyramide phosphate 150 MG Oral Capsule	PSN	31e79459-107f-4d69-a163-90014f1c4772	5
309958	disopyramide 100 MG Oral Capsule	SCD	31e79459-107f-4d69-a163-90014f1c4772	5
309960	disopyramide 150 MG Oral Capsule	SCD	31e79459-107f-4d69-a163-90014f1c4772	5
309958	disopyramide 100 MG (as disopyramide phosphate) Oral Capsule	SY	31e79459-107f-4d69-a163-90014f1c4772	5
309960	disopyramide 150 MG (as disopyramide phosphate) Oral Capsule	SY	31e79459-107f-4d69-a163-90014f1c4772	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59762-0386-1	59762038601	100 CAPSULE, GELATIN COATED in 1 BOTTLE (59762-0386-1)	2019-04-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Disopyramide phosphate capsules	Mylan Pharmaceuticals Inc. \| Pfizer Inc \| Pfizer Manufacturing Deutschland GmbH	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	5