Dilantin

Product NDC: 0071-3740
11-digit product format: 000713740
Labeler code: 0071
Product ID: 0071-3740_06311c9f-47af-4aae-a7a4-a0a40182ee7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Extended Phenytoin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Parke-Davis Div of Pfizer Inc
Application: ANDA084349
Marketing category: ANDA
Marketing start: 1976-08-27
Marketing end: 0000-00-00
Substance: PHENYTOIN SODIUM
Active strength: 30 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0071-3740		D	Discontinued by firm		2026-08-10
excluded package	package	0071-3740	0071-3740-66	D	Discontinued by firm		2026-08-10

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084349-001	DILANTIN	PHENYTOIN SODIUM	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982
A084349-002	DILANTIN	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084349-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084349-001	DILANTIN	30MG EXTENDED	CAPSULE / ORAL		RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A084349-002	DILANTIN	100MG EXTENDED	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`

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	A084349-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084349-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084349-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084349-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084349-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084349-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084349-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084349-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084349-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084349-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084349-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084349-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084349-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084349-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084349-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084349-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084349-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084349-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084349-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084349-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084349-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084349-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084349-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084349-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084349-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084349-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084349-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084349-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084349-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084349-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084349-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084349-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084349-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084349-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084349-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084349-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084349-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084349-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084349-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084349-002	AB	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0071-3740-66	EA - Each	0071-3740	d2a56e7e-4f9f-4f0a-b177-346aa20c3648	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]	24
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
PHENYTOIN SODIUM	ACTIVE INGREDIENT	4182431BJH	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0071-3740	DILANTIN (EXTENDED PHENYTOIN SODIUM) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	56	Legacy NDC	20250410_8848de76-8d74-4620-bcc7-a86a596e5dd9.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
DILANTIN	EXTENDED PHENYTOIN SODIUM	REMEDYREPACK INC.	db8c69b0-4697-433e-98c7-b0b2d2c52a83	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084349 application number: ANDA084349
DILANTIN	EXTENDED PHENYTOIN SODIUM	Viatris Specialty LLC	86dd27d1-9cee-48ae-b55d-e2d2f7dbc593	2023-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084349 application number: ANDA084349

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
855871	Dilantin 30 MG Extended Release Oral Capsule	PSN	4f918d15-908e-4c3a-94d6-71370da9a116	4
855869	phenytoin sodium 30 MG Extended Release Oral Capsule	PSN	4f918d15-908e-4c3a-94d6-71370da9a116	4
855871	phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]	SBD	4f918d15-908e-4c3a-94d6-71370da9a116	4
855869	phenytoin sodium 30 MG Extended Release Oral Capsule	SCD	4f918d15-908e-4c3a-94d6-71370da9a116	4
855871	Dilantin 30 MG Extended Release Oral Capsule	SY	4f918d15-908e-4c3a-94d6-71370da9a116	4
855869	DPH sodium 30 MG Extended Release Oral Capsule	SY	4f918d15-908e-4c3a-94d6-71370da9a116	4
855871	DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]	SY	4f918d15-908e-4c3a-94d6-71370da9a116	4
855673	Dilantin 100 MG Extended Release Oral Capsule	PSN	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855871	Dilantin 30 MG Extended Release Oral Capsule	PSN	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	PSN	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855869	phenytoin sodium 30 MG Extended Release Oral Capsule	PSN	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855673	phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]	SBD	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855871	phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]	SBD	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855671	phenytoin sodium 100 MG Extended Release Oral Capsule	SCD	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855869	phenytoin sodium 30 MG Extended Release Oral Capsule	SCD	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855673	Dilantin 100 MG Extended Release Oral Capsule	SY	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855871	Dilantin 30 MG Extended Release Oral Capsule	SY	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855671	DPH sodium 100 MG Extended Release Oral Capsule	SY	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855673	DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]	SY	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855869	DPH sodium 30 MG Extended Release Oral Capsule	SY	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855871	DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]	SY	1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f	2
855871	Dilantin 30 MG Extended Release Oral Capsule	PSN	5554a280-0490-4235-9c8c-bea141db6884	1
855869	phenytoin sodium 30 MG Extended Release Oral Capsule	PSN	5554a280-0490-4235-9c8c-bea141db6884	1
855871	phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]	SBD	5554a280-0490-4235-9c8c-bea141db6884	1
855869	phenytoin sodium 30 MG Extended Release Oral Capsule	SCD	5554a280-0490-4235-9c8c-bea141db6884	1
855871	Dilantin 30 MG Extended Release Oral Capsule	SY	5554a280-0490-4235-9c8c-bea141db6884	1
855869	DPH sodium 30 MG Extended Release Oral Capsule	SY	5554a280-0490-4235-9c8c-bea141db6884	1
855871	DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]	SY	5554a280-0490-4235-9c8c-bea141db6884	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0071-3740-66	00071374066	100 CAPSULE in 1 BOTTLE (0071-3740-66)	100 capsule	1976-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dilantin	REMEDYREPACK INC.	2022-05-24	HUMAN PRESCRIPTION DRUG LABEL	5
Dilantin	Parke-Davis Div of Pfizer Inc	2022-03-21	HUMAN PRESCRIPTION DRUG LABEL	57
Dilantin	Carilion Materials Management	2017-07-06	HUMAN PRESCRIPTION DRUG LABEL	4
Dilantin ® (extended phenytoin sodium capsules, USP)	Avera McKennan Hospital	2015-12-03	HUMAN PRESCRIPTION DRUG LABEL	1
Dilantin ® (Extended Phenytoin Sodium Capsules, USP)	Physicians Total Care, Inc.	2010-03-04	HUMAN PRESCRIPTION DRUG LABEL	2