Extended Phenytoin Sodium

Product NDC: 70518-2227
Requested package NDC: 70518-2227-3
11-digit product format: 705182227
Labeler code: 70518
Product ID: 70518-2227_dafbca02-f4e8-e19e-e053-2995a90acee1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA204309
Marketing category: ANDA
Marketing start: 2019-07-19
Marketing end: 0000-00-00
Substance: PHENYTOIN SODIUM
Active strength: 100 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	70518-2227	70518-2227-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2227	70518-2227-3	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Extended Phenytoin Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYTOIN SODIUM	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4182431BJH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855671	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
363cd347-d25e-42b9-9ce7-30642f3cb353	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
be8c0c29-be12-4cae-8e3b-1c71ed6b952c	Product name	2	20250626
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
e3d31abf-5149-4e77-89a8-0dc73ec106f9	Product name	1	20210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb	Product name	2	20200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2227	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [REMEDYREPACK INC.]	13	Legacy NDC	20250309_363cd347-d25e-42b9-9ce7-30642f3cb353.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 · 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 ndc (package): 70518-2227-3 ndc (product): 70518-2227 ndc11 (package): 70518222703
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	Sample	Status
70518-2227-3	70518222703	30 CAPSULE in 1 BLISTER PACK (70518-2227-3)	30 capsule	2024-06-29	0	Current