Phenytoin Infatabs

Product NDC: 66993-372
11-digit product format: 669930372
Labeler code: 66993
Product ID: 66993-372_e2f4f249-b837-4362-8854-a6c3960e1f94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Prasco Laboratories
Application: ANDA084427
Marketing category: ANDA
Marketing start: 2021-11-23
Substance: PHENYTOIN
Active strength: 50 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: 2026-12-31
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
A084427-001	DILANTIN	PHENYTOIN	50MG	TABLET, CHEWABLE / 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
A084427-001	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084427-001	DILANTIN	50MG	TABLET, CHEWABLE / ORAL	AB	RLD, RS, Approved before 1982	`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	A084427-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084427-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084427-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084427-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084427-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084427-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084427-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084427-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084427-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084427-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084427-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084427-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084427-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084427-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084427-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084427-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084427-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084427-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084427-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084427-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084427-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084427-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084427-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084427-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084427-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084427-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084427-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084427-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084427-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084427-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084427-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084427-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084427-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084427-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084427-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084427-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084427-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084427-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084427-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084427-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYTOIN	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6158TKW0C5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1313885	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
3580e6a8-f7c3-44a0-a1eb-2a84ae589d21	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	Strength	SPL version
66993-372-02	Phenytoin Infatabs	100 in 1 BOTTLE	TABLET, CHEWABLE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-372-02	EA - Each	66993-372	4d8029f4-1742-42ae-b491-d0e02338d72f	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-372	PHENYTOIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PRASCO LABORATORIES]	5	Current NDC, Legacy NDC, 1 package rows	20250122_3580e6a8-f7c3-44a0-a1eb-2a84ae589d21.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenytoin Infatabs	PHENYTOIN	Prasco Laboratories	3580e6a8-f7c3-44a0-a1eb-2a84ae589d21	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084427 application number: ANDA084427 ndc (product): 66993-372
Dilantin Infatabs	PHENYTOIN	Parke-Davis Div of Pfizer Inc	ca119a89-2394-4d34-8078-cd1fa4e8e2f1	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084427 application number: ANDA084427
Phenytoin Infatabs	PHENYTOIN	NCS HealthCare of KY, LLC dba Vangard Labs	0d240b2b-bc5c-4989-a20b-54ed37a09a4f	2024-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084427 application number: ANDA084427

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6158TKW0C5	PHENYTOIN	57-41-0	PHENYTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1313885	phenytoin 50 MG Chewable Tablet	PSN	3580e6a8-f7c3-44a0-a1eb-2a84ae589d21	7
1313885	phenytoin 50 MG Chewable Tablet	SCD	3580e6a8-f7c3-44a0-a1eb-2a84ae589d21	7
1313885	DPH 50 MG Chewable Tablet	SY	3580e6a8-f7c3-44a0-a1eb-2a84ae589d21	7
1313885	phenytoin 50 MG Chewable Tablet	PSN	0d240b2b-bc5c-4989-a20b-54ed37a09a4f	6
1313885	phenytoin 50 MG Chewable Tablet	SCD	0d240b2b-bc5c-4989-a20b-54ed37a09a4f	6
1313885	DPH 50 MG Chewable Tablet	SY	0d240b2b-bc5c-4989-a20b-54ed37a09a4f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-372-02	66993037202	100 TABLET, CHEWABLE in 1 BOTTLE (66993-372-02)	2021-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenytoin Infatabs	Prasco Laboratories \| Pfizer Inc \| Pharmacia & Upjohn Company LLC \| Pfizer Italia S.r.l.	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	7
Phenytoin Infatabs	REMEDYREPACK INC.	2024-07-26	HUMAN PRESCRIPTION DRUG LABEL	1
Phenytoin Infatabs	NCS HealthCare of KY, LLC dba Vangard Labs	2024-04-11	HUMAN PRESCRIPTION DRUG LABEL	6