PHENYTOIN SODIUM

Product NDC: 51662-1251
11-digit product format: 516621251
Labeler code: 51662
Product ID: 51662-1251_0f8e2789-a18e-bfe6-e063-6394a90abbe9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PHENYTOIN SODIUM
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA084307
Marketing category: ANDA
Marketing start: 2018-09-16
Substance: PHENYTOIN SODIUM
Active strength: 50 mg/mL
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
A084307-001	PHENYTOIN SODIUM	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	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
A084307-001	AP

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	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084307-001	PHENYTOIN SODIUM	50MG/ML	INJECTABLE / INJECTION	AP	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	A084307-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084307-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084307-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084307-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084307-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084307-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084307-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084307-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084307-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084307-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084307-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084307-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084307-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084307-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084307-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084307-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084307-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084307-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084307-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084307-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084307-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084307-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084307-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084307-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084307-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084307-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084307-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084307-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084307-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084307-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084307-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084307-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084307-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084307-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084307-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084307-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084307-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084307-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084307-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084307-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYTOIN SODIUM	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4182431BJH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1670351	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
7607ddff-2f1c-272c-e053-2991aa0a1ab3	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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51662-1251-1	2020-02-07	C162847	48780-1	9d75b9d0-bc23-f424-e053-dadaa90a57ce	PHENYTOIN SODIUM INJ., USP 100mg/2mL (50mg/mL) VIAL
51662-1251-1	2020-01-31	C162847	48780-1	9d75b9d0-bc23-f424-e053-dadaa90a57ce	PHENYTOIN SODIUM INJ., USP 100mg/2mL (50mg/mL) VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1251-1	PHENYTOIN SODIUM	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2	6
51662-1251-2	PHENYTOIN SODIUM	2 mL in 1 VIAL	INJECTION	2	6
51662-1251-2	PHENYTOIN SODIUM	1 in 1 POUCH	INJECTION	1	6
51662-1251-3	PHENYTOIN SODIUM	25 in 1 BOX	INJECTION	25	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1251	PHENYTOIN SODIUM INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	6	Current NDC, Legacy NDC, 4 package rows	20240123_7607ddff-2f1c-272c-e053-2991aa0a1ab3.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phenytoin Sodium	PHENYTOIN SODIUM	ProPharma Distribution	43060ca9-58a7-3371-e063-6294a90a5799	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307
Phenytoin Sodium	PHENYTOIN SODIUM	Henry Schein, Inc.	889dd22c-46f0-48d0-b18e-a3783c5fa653	2025-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307
PHENYTOIN SODIUM	PHENYTOIN SODIUM	Henry Schein, Inc.	a52cf1bd-dc1f-47be-aba8-29066d9a50fb	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307
Phenytoin Sodium	PHENYTOIN SODIUM	Hikma Pharmaceuticals USA Inc.	035a8d4e-2063-4240-83cb-d7eebcabe301	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307
Phenytoin Sodium	PHENYTOIN SODIUM	Hikma Pharmaceuticals USA Inc.	8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7	2024-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307
PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	7607ddff-2f1c-272c-e053-2991aa0a1ab3	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307 ndc (product): 51662-1251
Phenytoin Sodium	PHENYTOIN SODIUM	Medical Purchasing Solutions, LLC	0aac9dcd-c4df-84d9-e063-6294a90a0376	2023-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307
PHENYTOIN SODIUM	PHENYTOIN SODIUM	HF Acquisition Co LLC, DBA HealthFirst	763b549d-9b78-09dd-e053-2a91aa0aec7f	2022-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084307 application number: ANDA084307

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
1670351	phenytoin sodium 100 MG in 2 ML Injection	PSN	7607ddff-2f1c-272c-e053-2991aa0a1ab3	6
1670351	2 ML phenytoin sodium 50 MG/ML Injection	SCD	7607ddff-2f1c-272c-e053-2991aa0a1ab3	6
1670351	2 ML DPH sodium 50 MG/ML Injection	SY	7607ddff-2f1c-272c-e053-2991aa0a1ab3	6
1670351	phenytoin sodium 100 MG per 2 ML Injection	SY	7607ddff-2f1c-272c-e053-2991aa0a1ab3	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1251-1	51662125101	2 mL in 1 VIAL, SINGLE-DOSE (51662-1251-1)	2 ml	2018-09-16	0000-00-00	No	No	Current
51662-1251-2	51662125102	2 mL in 1 VIAL	2 ml					Historical
51662-1251-3	51662125103	25 POUCH in 1 BOX (51662-1251-3) / 1 VIAL in 1 POUCH (51662-1251-2) / 2 mL in 1 VIAL	25 pouch	2022-03-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PHENYTOIN SODIUM INJ., USP 100mg/2mL (50mg/mL) VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-22	HUMAN PRESCRIPTION DRUG LABEL	6