Phenytoin

Product NDC: 51672-4069
11-digit product format: 516724069
Labeler code: 51672
Product ID: 51672-4069_3cbd8a0c-6cfb-e0dd-e063-6394a90a8a26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phenytoin
Dosage form: SUSPENSION
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA040521
Marketing category: ANDA
Marketing start: 2004-04-08
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: 2026-12-31
Current FDA listing: Yes

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	51672-4069	51672-4069-1	D	Discontinued by firm		2026-08-03

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phenytoin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYTOIN	125 mg/5mL

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
1313112	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
093fd736-5971-47af-b4ef-08c1696cebe8	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
e3d31abf-5149-4e77-89a8-0dc73ec106f9	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecb	Product name	2	20200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
51672-4069-1	Phenytoin	237 mL in 1 BOTTLE	SUSPENSION	237	17
51672-4069-2	Phenytoin	237 mL in 1 BOTTLE	SUSPENSION	237	17
51672-4069-2	Phenytoin	1 in 1 CARTON	SUSPENSION	1	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4069-1	ML - Milliliter	51672-4069	ad64fdf1-fd54-465f-ac07-356560e8268f	1	2012-07-24
51672-4069-2	ML - Milliliter	51672-4069	bce3d4d5-d92a-43ce-83b8-eaf43c3eb969	1	2025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phenytoin	ACTIVE INGREDIENT	6158TKW0C5	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
Phenytoin	ACTIVE MOIETY	6158TKW0C5	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
magnesium aluminum silicate	INACTIVE INGREDIENT	6M3P64V0NC	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
sucrose	INACTIVE INGREDIENT	C151H8M554	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
water	INACTIVE INGREDIENT	059QF0KO0R	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	6
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4069	PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]	14	Current NDC, Legacy NDC, 3 package rows	20220429_093fd736-5971-47af-b4ef-08c1696cebe8.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 · 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 ndc (product): 51672-4069
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1313112	phenytoin 125 MG in 5 mL Oral Suspension	PSN	093fd736-5971-47af-b4ef-08c1696cebe8	17
1313112	phenytoin 25 MG/ML Oral Suspension	SCD	093fd736-5971-47af-b4ef-08c1696cebe8	17
1313112	DPH 25 MG/ML Oral Suspension	SY	093fd736-5971-47af-b4ef-08c1696cebe8	17
1313112	phenytoin 100 MG per 4 ML Oral Suspension	SY	093fd736-5971-47af-b4ef-08c1696cebe8	17
1313112	phenytoin 125 MG per 5 ML Oral Suspension	SY	093fd736-5971-47af-b4ef-08c1696cebe8	17
1313112	phenytoin 125 MG in 5 mL Oral Suspension	PSN	f9fe4c92-2761-4cb4-9cf3-7066e240e014	6
1313112	phenytoin 25 MG/ML Oral Suspension	SCD	f9fe4c92-2761-4cb4-9cf3-7066e240e014	6
1313112	DPH 25 MG/ML Oral Suspension	SY	f9fe4c92-2761-4cb4-9cf3-7066e240e014	6
1313112	phenytoin 100 MG per 4 ML Oral Suspension	SY	f9fe4c92-2761-4cb4-9cf3-7066e240e014	6
1313112	phenytoin 125 MG per 5 ML Oral Suspension	SY	f9fe4c92-2761-4cb4-9cf3-7066e240e014	6
1313112	phenytoin 125 MG in 5 mL Oral Suspension	PSN	09daf485-3355-44cb-92af-072dd281e129	5
1313112	phenytoin 25 MG/ML Oral Suspension	SCD	09daf485-3355-44cb-92af-072dd281e129	5
1313112	DPH 25 MG/ML Oral Suspension	SY	09daf485-3355-44cb-92af-072dd281e129	5
1313112	phenytoin 100 MG per 4 ML Oral Suspension	SY	09daf485-3355-44cb-92af-072dd281e129	5
1313112	phenytoin 125 MG per 5 ML Oral Suspension	SY	09daf485-3355-44cb-92af-072dd281e129	5
1313112	phenytoin 125 MG in 5 mL Oral Suspension	PSN	f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15	4
1313112	phenytoin 25 MG/ML Oral Suspension	SCD	f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15	4
1313112	DPH 25 MG/ML Oral Suspension	SY	f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15	4
1313112	phenytoin 100 MG per 4 ML Oral Suspension	SY	f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15	4
1313112	phenytoin 125 MG per 5 ML Oral Suspension	SY	f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4069-1	51672406901	237 mL in 1 BOTTLE (51672-4069-1)	237 ml	2004-04-08	2026-07-31	No	No	Current
51672-4069-2	51672406902	1 BOTTLE in 1 CARTON (51672-4069-2) / 237 mL in 1 BOTTLE	1 bottle	2025-07-23		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phenytoin	American Health Packaging	2025-09-17	HUMAN PRESCRIPTION DRUG LABEL	6
Phenytoin	Sun Pharmaceutical Industries, Inc. \| Taro Pharmaceutical Industries Ltd.	2025-08-19	HUMAN PRESCRIPTION DRUG LABEL	17
Phenytoin	ATLANTIC BIOLOGICALS CORP.	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	5
Phenytoin	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2024-11-19	HUMAN PRESCRIPTION DRUG LABEL	4
Phenytoin	REMEDYREPACK INC.	2023-06-15	HUMAN PRESCRIPTION DRUG LABEL	6
Phenytoin	Major Pharmaceuticals	2022-12-30	HUMAN PRESCRIPTION DRUG LABEL	2
Phenytoin Oral Suspension, USP	ATLANTIC BIOLOGICALS CORP.	2021-01-25	HUMAN PRESCRIPTION DRUG LABEL	7