Phenytoin

Product NDC: 17856-4069
11-digit product format: 178564069
Labeler code: 17856
Product ID: 17856-4069_72a45cbd-e2e7-4804-b314-813fe1b64d58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin
Dosage form: SUSPENSION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA040521
Marketing category: ANDA
Marketing start: 2004-04-08
Marketing end: 0000-00-00
Substance: PHENYTOIN
Active strength: 125 mg/5mL
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-4069		D	Discontinued by firm	2026-08-11
excluded package	package	17856-4069	17856-4069-1	D	Discontinued by firm	2026-08-11
excluded package	package	17856-4069	17856-4069-4	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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-4069-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-4069-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-4069-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-4069-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-4069-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-4069-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-4069-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-4069-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-4069-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-4069-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-4069-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-4069-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-4069-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-4069-4	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-4069-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-4069-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-4069-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-4069-4	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-4069-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-4069-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-4069-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-4069-4	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-4069-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-4069-4	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A040521-001	PHENYTOIN	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB		2004-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040521-001	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	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040521-001	PHENYTOIN	125MG/5ML	SUSPENSION / ORAL	AB	2004-03-08	`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	A040521-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040521-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040521-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040521-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040521-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040521-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040521-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040521-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040521-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040521-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040521-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040521-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040521-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040521-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040521-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040521-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040521-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040521-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040521-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040521-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040521-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040521-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040521-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040521-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040521-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040521-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040521-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040521-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040521-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040521-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040521-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040521-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040521-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040521-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040521-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040521-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040521-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040521-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040521-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040521-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-4069-4	ML - Milliliter	17856-4069	a5e49d3a-8c2b-4491-a439-bc47dbf5ebac	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phenytoin	ACTIVE INGREDIENT	6158TKW0C5	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5
Phenytoin	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]	5

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenytoin	PHENYTOIN	American Health Packaging	f9fe4c92-2761-4cb4-9cf3-7066e240e014	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040521 application number: ANDA040521
Phenytoin	PHENYTOIN	Sun Pharmaceutical Industries, Inc.	093fd736-5971-47af-b4ef-08c1696cebe8	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040521 application number: ANDA040521
Phenytoin	PHENYTOIN	ATLANTIC BIOLOGICALS CORP.	09daf485-3355-44cb-92af-072dd281e129	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040521 application number: ANDA040521
Phenytoin	PHENYTOIN	PAI Holdings, LLC dba PAI Pharma	f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15	2024-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040521 application number: ANDA040521

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
17856-4069-4	17856406904	4.8 mL in 1 CUP (17856-4069-4)	4.8 ml	2021-01-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenytoin Oral Suspension, USP	ATLANTIC BIOLOGICALS CORP.	2021-01-25	HUMAN PRESCRIPTION DRUG LABEL	7