PHENYTOIN SODIUM

Product NDC: 62756-402
11-digit product format: 627560402
Labeler code: 62756
Product ID: 62756-402_9f1bb601-e3fa-4c9a-9021-5a6a0a9b60c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENYTOIN SODIUM
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA040621
Marketing category: ANDA
Marketing start: 2006-12-12
Marketing end: 0000-00-00
Substance: PHENYTOIN SODIUM
Active strength: 100 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62756-402		I	Inactivated by FDA	2026-08-17
excluded package	package	62756-402	62756-402-01	I	Inactivated by FDA	2026-08-17
excluded package	package	62756-402	62756-402-02	I	Inactivated by FDA	2026-08-17
excluded package	package	62756-402	62756-402-03	I	Inactivated by FDA	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 84 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62756-402-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62756-402-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62756-402-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62756-402-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62756-402-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62756-402-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62756-402-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62756-402-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62756-402-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62756-402-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62756-402-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62756-402-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62756-402-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62756-402-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62756-402-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62756-402-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62756-402-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62756-402-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62756-402-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62756-402-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62756-402-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62756-402-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62756-402-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62756-402-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62756-402-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62756-402-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62756-402-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62756-402-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62756-402-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62756-402-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62756-402-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62756-402-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62756-402-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62756-402-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62756-402-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62756-402-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62756-402-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62756-402-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62756-402-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62756-402-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62756-402-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62756-402-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62756-402-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62756-402-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62756-402-02	`1332a3947898…`	`d4bfe170f9cd…`

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
A040621-001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL			2006-12-11

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2006-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040621-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL		2006-12-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A040621-001	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
be8c0c29-be12-4cae-8e3b-1c71ed6b952c	Product name	2	20250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9	Product name	1	20210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb	Product name	2	20200303
031bbc61-0564-1f35-2716-aa5c1d139248	Product name	2	20141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70	Product name	1	20140508
eafc3fd3-6834-3129-5bbb-8a9a495691ab	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62756-402-01	2020-01-31	C162847	48780-1	9d75b9d0-6460-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
62756-402-02	2020-01-31	C162847	48780-1	9d75b9d0-6460-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
62756-402-03	2020-01-31	C162847	48780-1	9d75b9d0-6460-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62756-402-01	PHENYTOIN SODIUM	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	10
62756-402-02	PHENYTOIN SODIUM	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	10
62756-402-03	PHENYTOIN SODIUM	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-402-01	EA - Each	62756-402	0c62cb04-72e4-4e7f-b1c8-a88e9dc6747d	1	2012-07-24
62756-402-03	EA - Each	62756-402	913103cf-391f-41ca-bd56-250bf0e0ddee	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
LACTITOL MONOHYDRATE	INACTIVE INGREDIENT	UH2K6W1Y64	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	6
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
LACTITOL MONOHYDRATE	INACTIVE INGREDIENT	UH2K6W1Y64	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-402	PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	10	Legacy NDC, 3 package rows	20181024_422408c1-ca13-4743-9773-9641eca28f18.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4182431BJH	PHENYTOIN SODIUM	630-93-3	PHENYTOIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	422408c1-ca13-4743-9773-9641eca28f18	10
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	422408c1-ca13-4743-9773-9641eca28f18	10
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	422408c1-ca13-4743-9773-9641eca28f18	10
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	7f20cf98-1a63-4eaf-a7ac-fa5d79a045e0	5
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	7f20cf98-1a63-4eaf-a7ac-fa5d79a045e0	5
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	7f20cf98-1a63-4eaf-a7ac-fa5d79a045e0	5
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	5268708d-770f-0a29-e054-00144ff88e88	2
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	5268708d-770f-0a29-e054-00144ff88e88	2
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	5268708d-770f-0a29-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
62756-402-01	62756040201	100 in 1 BOTTLE	Historical
62756-402-02	62756040202	100 in 1 BOTTLE	Historical
62756-402-03	62756040203	1000 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENYTOIN SODIUM	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	5
PHENYTOIN SODIUM	Bryant Ranch Prepack	2020-10-16	Human Prescription Drug Label	4
PHENYTOIN SODIUM	Bryant Ranch Prepack	2020-10-16	Human Prescription Drug Label	4
PHENYTOIN SODIUM - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
PHENYTOIN SODIUM	Bryant Ranch Prepack	2020-01-19	Human Prescription Drug Label	3
EXTENDED PHENYTOIN SODIUM CAPSULES, USP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
PHENYTOIN SODIUM	REMEDYREPACK INC.	2019-08-06	HUMAN PRESCRIPTION DRUG LABEL	3
EXTENDED PHENYTOIN SODIUM CAPSULES, USP	Clinical Solutions Wholesale	2019-07-12	HUMAN PRESCRIPTION DRUG LABEL	7
PHENYTOIN SODIUM	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2018-10-24	Human Prescription Drug Label	10