Phenytoin

Product NDC: 66689-036
Requested package NDC: 66689-036-50
11-digit product format: 666890036
Labeler code: 66689
Product ID: 66689-036_c24a0d96-5333-4123-b595-44136ad7bc43
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin
Dosage form: SUSPENSION
Route: ORAL
Labeler: VistaPharm, Inc.
Application: ANDA040342
Marketing category: ANDA
Marketing start: 2010-05-10
Marketing end: 0000-00-00
Substance: PHENYTOIN
Active strength: 125 mg/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	66689-036	66689-036-50	D	Discontinued by firm		2026-08-11

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	66689-036	66689-036-50	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66689-036	66689-036-50	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040342-001	PHENYTOIN	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL			2001-01-31
A040342-002	PHENYTOIN	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL			2005-08-18

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 · 70 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	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2001-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL		2005-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040342-002	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2005-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040342-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2001-01-31	`3f01610625f2…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040342-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040342-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040342-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040342-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040342-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040342-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040342-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040342-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040342-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040342-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040342-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040342-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040342-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040342-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040342-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040342-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040342-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040342-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040342-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040342-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040342-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040342-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040342-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040342-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040342-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040342-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040342-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040342-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040342-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040342-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040342-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040342-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040342-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040342-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040342-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A040342-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040342-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A040342-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040342-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040342-002	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66689-036-50	2024-01-30	C162847	48780-1	1030e364-fcc6-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use PHENYTOIN ORAL SUSPENSION safely and effectively. See full prescribing information for PHENYTOIN ORAL SUSPENSION. PHENYTOIN oral suspension Initial U.S. Approval: 1953

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-036-01	ML - Milliliter	66689-036	55e6e511-b376-4b6d-9876-c161285ad4c2	1	2012-07-24
66689-036-50	ML - Milliliter	66689-036	099bc12b-07cc-470d-8e68-2718eb515a9d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phenytoin	ACTIVE INGREDIENT	6158TKW0C5	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
Phenytoin	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
Magnesium Aluminum Silicate	INACTIVE INGREDIENT	6M3P64V0NC	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
Sucrose	INACTIVE INGREDIENT	C151H8M554	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	PHENYTOIN SUSPENSION [VISTAPHARM INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66689-036	PHENYTOIN SUSPENSION [VISTAPHARM, LLC]	19	Legacy NDC	20240510_85cc5cd9-695f-4a71-9275-e0099c505185.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66689-036-50	66689003650	5 TRAY in 1 CASE (66689-036-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (66689-036-01)	5 tray	2010-05-10	0000-00-00	No	No	Current