Phenytoin Sodium

Product NDC
0641-6139
11-digit product format
006416139
Labeler code
0641
Product ID
0641-6139_8c2cd4dc-57c1-48b8-8005-95c5a5593e7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA084307
Marketing category
ANDA
Marketing start
1975-07-16
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084307-001PHENYTOIN SODIUMPHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A084307-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084307-001PHENYTOIN SODIUM50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A084307-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084307-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084307-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084307-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084307-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084307-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084307-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084307-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084307-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084307-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084307-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084307-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084307-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084307-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084307-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084307-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084307-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084307-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084307-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084307-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084307-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A084307-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084307-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084307-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084307-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A084307-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084307-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084307-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084307-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084307-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084307-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084307-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084307-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084307-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A084307-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A084307-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084307-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084307-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084307-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084307-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4182431BJHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1670351Internal RxNorm lookup
1670353Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6139-01Phenytoin Sodium5 mL in 1 VIALINJECTION521
0641-6139-10Phenytoin Sodium10 in 1 CARTONINJECTION1021
0641-6139-25Phenytoin Sodium25 in 1 CARTONINJECTION2521

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6139-01ML - Milliliter0641-6139acb3c689-f9f2-49fb-9293-ffc39fbb833d12013-05-02
0641-6139-10ML - Milliliter0641-61396409258a-4fe5-4ba3-93a9-9994dafe6fb712024-01-04
0641-6139-25ML - Milliliter0641-6139cf823b58-ba24-40bf-92dd-f0ad970353fe12013-05-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6139PHENYTOIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]21Current NDC, Legacy NDC, 3 package rows20240410_8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e7.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenytoin SodiumPHENYTOIN SODIUMProPharma Distribution43060ca9-58a7-3371-e063-6294a90a57992025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084307
application number: ANDA084307
Phenytoin SodiumPHENYTOIN SODIUMHenry Schein, Inc.889dd22c-46f0-48d0-b18e-a3783c5fa6532025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084307
application number: ANDA084307
PHENYTOIN SODIUMPHENYTOIN SODIUMHenry Schein, Inc.a52cf1bd-dc1f-47be-aba8-29066d9a50fb2024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084307
application number: ANDA084307
Phenytoin SodiumPHENYTOIN SODIUMHikma Pharmaceuticals USA Inc.035a8d4e-2063-4240-83cb-d7eebcabe3012024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084307
application number: ANDA084307
Phenytoin SodiumPHENYTOIN SODIUMHikma Pharmaceuticals USA Inc.8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e72024-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084307
application number: ANDA084307
ndc (product): 0641-6139
PHENYTOIN SODIUMPHENYTOIN SODIUMHF Acquisition Co LLC, DBA HealthFirst7607ddff-2f1c-272c-e053-2991aa0a1ab32024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084307
application number: ANDA084307
Phenytoin SodiumPHENYTOIN SODIUMMedical Purchasing Solutions, LLC0aac9dcd-c4df-84d9-e063-6294a90a03762023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084307
application number: ANDA084307
PHENYTOIN SODIUMPHENYTOIN SODIUMHF Acquisition Co LLC, DBA HealthFirst763b549d-9b78-09dd-e053-2a91aa0aec7f2022-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084307
application number: ANDA084307

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670351phenytoin sodium 100 MG in 2 ML InjectionPSN8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e721
1670353phenytoin sodium 250 MG in 5 ML InjectionPSN8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e721
16703512 ML phenytoin sodium 50 MG/ML InjectionSCD8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e721
16703535 ML phenytoin sodium 50 MG/ML InjectionSCD8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e721
16703512 ML DPH sodium 50 MG/ML InjectionSY8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e721
16703535 ML DPH sodium 50 MG/ML InjectionSY8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e721
1670351phenytoin sodium 100 MG per 2 ML InjectionSY8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e721
1670353phenytoin sodium 250 MG per 5 ML InjectionSY8ad1be7b-a1a4-4a2a-bf9b-d22b350aa6e721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6139-01006416139015 mL in 1 VIAL5 mlHistorical
0641-6139-100064161391010 VIAL in 1 CARTON (0641-6139-10) / 5 mL in 1 VIAL (0641-6139-01) 10 vial2023-09-22NoNoCurrent
0641-6139-250064161392525 VIAL in 1 CARTON (0641-6139-25) / 5 mL in 1 VIAL (0641-6139-01) 25 vial1975-07-160000-00-00NoNoCurrent