Extended Phenytoin Sodium

Product NDC: 50090-3165
Requested package NDC: 50090-3165-0
11-digit product format: 500903165
Labeler code: 50090
Product ID: 50090-3165_616412f7-f49a-4469-a8f0-dbe32697db74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA204309
Marketing category: ANDA
Marketing start: 2015-06-10
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3165	50090-3165-0	D	Discontinued by firm		2026-08-11

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 1 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3165	50090-3165-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3165	50090-3165-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

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
A204309-001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB		2015-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204309-001	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 2 · 41 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	A204309-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204309-001	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2015-06-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204309-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204309-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204309-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204309-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204309-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204309-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204309-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204309-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204309-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204309-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204309-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204309-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204309-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204309-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204309-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204309-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204309-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204309-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204309-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204309-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204309-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204309-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204309-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204309-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204309-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204309-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204309-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204309-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204309-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204309-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204309-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204309-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204309-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204309-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204309-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204309-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204309-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204309-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204309-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204309-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-3165-0	2023-02-06	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
50090-3165-1	2023-02-06	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
50090-3165-0	2023-01-30	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
50090-3165-1	2023-01-30	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3165-0	EA - Each	50090-3165	d5bab16f-345a-47f3-b2c9-f4a2ae2c5547	1	2019-05-02
50090-3165-1	EA - Each	50090-3165	96fc9e84-d4fe-4b38-9e88-f3c00c9e5fbe	1	2021-09-07

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extended Phenytoin Sodium	PHENYTOIN SODIUM	REMEDYREPACK INC.	363cd347-d25e-42b9-9ce7-30642f3cb353	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309
Extended Phenytoin Sodium	PHENYTOIN SODIUM	Bryant Ranch Prepack	a9a1059e-63a2-486e-aa50-eda388f79525	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309
Extended Phenytoin Sodium	PHENYTOIN SODIUM	American Health Packaging	5b64cb11-673a-41ec-9b2a-1e194ae5eb0c	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309
Extended Phenytoin Sodium	PHENYTOIN SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	a7bfb3aa-5226-4a48-8156-a9ecc4536fdf	2024-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309
Extended Phenytoin Sodium	PHENYTOIN SODIUM	Aurobindo Pharma Limited	5362ea50-38a4-48b4-a85b-d634c3d8b91a	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204309 application number: ANDA204309

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3165-0	50090316500	100 CAPSULE in 1 BOTTLE (50090-3165-0)	100 capsule	2017-10-12	0000-00-00	No	No	Current