Extended Phenytoin Sodium

Product NDC: 65162-212
11-digit product format: 651620212
Labeler code: 65162
Product ID: 65162-212_ba4af35a-0bb4-4c62-bf75-174b2b5a5aba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA040765
Marketing category: ANDA
Marketing start: 2009-12-16
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: 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 · 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…`

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
7e467c02-49a0-4b62-b537-430fdfa4f10e	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-212-03	Extended Phenytoin Sodium	30 in 1 BOTTLE	CAPSULE	30	27
65162-212-10	Extended Phenytoin Sodium	100 in 1 BOTTLE	CAPSULE	100	27
65162-212-11	Extended Phenytoin Sodium	1000 in 1 BOTTLE	CAPSULE	1000	27
65162-212-50	Extended Phenytoin Sodium	500 in 1 BOTTLE	CAPSULE	500	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-212-10	EA - Each	65162-212	997d2ccb-f46e-4f16-b268-946e6c6c9fab	1	2012-07-24
65162-212-11	EA - Each	65162-212	e2c3ef5e-7476-437f-8920-eff23b20d755	1	2012-07-24
65162-212-50	EA - Each	65162-212	b0c46b0b-74bc-4a0d-bad6-85174a697bf7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	13
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]	8
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMERICAN HEALTH PACKAGING]	4
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	PHENYTOIN SODIUM CAPSULE [DIRECT RX]	1
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SODIUM CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-212	EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMNEAL PHARMACEUTICALS LLC]	26	Current NDC, Legacy NDC, 4 package rows	20241027_7e467c02-49a0-4b62-b537-430fdfa4f10e.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 ndc (product): 65162-212
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

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	df0bf42b-ce9a-42c3-8c24-46f1ea3bd214	4
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	df0bf42b-ce9a-42c3-8c24-46f1ea3bd214	4
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	df0bf42b-ce9a-42c3-8c24-46f1ea3bd214	4
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	295acc10-5c96-437c-946f-112f7e6a09c8	1
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	295acc10-5c96-437c-946f-112f7e6a09c8	1
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	295acc10-5c96-437c-946f-112f7e6a09c8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-212-03	65162021203	30 CAPSULE in 1 BOTTLE (65162-212-03)	30 capsule	2009-12-16	0000-00-00	No	No	Current
65162-212-10	65162021210	100 CAPSULE in 1 BOTTLE (65162-212-10)	100 capsule	2009-12-16	0000-00-00	No	No	Current
65162-212-11	65162021211	1000 CAPSULE in 1 BOTTLE (65162-212-11)	1000 capsule	2009-12-16	0000-00-00	No	No	Current
65162-212-50	65162021250	500 CAPSULE in 1 BOTTLE (65162-212-50)	500 capsule	2009-12-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Extended Phenytoin Sodium	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	29
PHENYTOIN SODIUM	DIRECT RX	2026-02-27	HUMAN PRESCRIPTION DRUG LABEL	4
Extended Phenytoin Sodium	AvKARE	2025-02-13	HUMAN PRESCRIPTION DRUG LABEL	4
Extended Phenytoin Sodium	PD-Rx Pharmaceuticals, Inc.	2024-10-11	HUMAN PRESCRIPTION DRUG LABEL	18
Extended Phenytoin Sodium	Major Pharmaceuticals	2024-06-17	HUMAN PRESCRIPTION DRUG LABEL	9
Extended Phenytoin Sodium	American Health Packaging	2024-02-02	HUMAN PRESCRIPTION DRUG LABEL	11
Extended Phenytoin Sodium	A-S Medication Solutions	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	6
Extended Phenytoin Sodium	REMEDYREPACK INC.	2019-03-01	HUMAN PRESCRIPTION DRUG LABEL	5
Extended Phenytoin Sodium Capsules, USP	State of Florida DOH Central Pharmacy	2014-09-30	HUMAN PRESCRIPTION DRUG LABEL	1