Extended Phenytoin Sodium

Product NDC: 71610-479
Requested package NDC: 71610-479-98
11-digit product format: 716100479
Labeler code: 71610
Product ID: 71610-479_444cd2c3-a0d4-4c73-b74e-284a212f288b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA040765
Marketing category: ANDA
Marketing start: 2020-08-25
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: 2021-12-31
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	71610-479	71610-479-98	D	Discontinued by firm		2026-08-11

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
A040765-001	EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB		2008-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040765-001	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	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040765-001	EXTENDED PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	2008-11-12	`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	A040765-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040765-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040765-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040765-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040765-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040765-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040765-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040765-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040765-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040765-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040765-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040765-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040765-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040765-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040765-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040765-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040765-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040765-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040765-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040765-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040765-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040765-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040765-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040765-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040765-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040765-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040765-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040765-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040765-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040765-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040765-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040765-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040765-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040765-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040765-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040765-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040765-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040765-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040765-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040765-001	AB	1	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-479	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20201113_f163208c-25e7-415b-ae17-9f5f5870e6e8.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
Extended Phenytoin Sodium	PHENYTOIN SODIUM	Amneal Pharmaceuticals LLC	7e467c02-49a0-4b62-b537-430fdfa4f10e	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040765 application number: ANDA040765
PHENYTOIN SODIUM	PHENYTOIN SODIUM	DIRECT RX	df0bf42b-ce9a-42c3-8c24-46f1ea3bd214	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040765 application number: ANDA040765

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
71610-479-98	71610047998	540 CAPSULE in 1 BOTTLE (71610-479-98)	540 capsule	2020-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Extended Phenytoin Sodium	Aphena Pharma Solutions - Tennessee, LLC	2020-11-12	HUMAN PRESCRIPTION DRUG LABEL	1