FDA.reportPublic FDA data

PHENYTOIN SODIUM

Product NDC
42192-614
11-digit product format
421920614
Labeler code
42192
Product ID
42192-614_ae14cce7-f65a-45e0-8ff4-9388d0a806d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYTOIN SODIUM
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Acella Pharmaceuticals, LLC
Application
ANDA040573
Marketing category
ANDA
Marketing start
2021-12-01
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

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 Identifiers#

Field, Values table
FieldValues
Unii4182431BJH
Rxcui1670351, 1670353

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
42192-614-10PHENYTOIN SODIUM10 in 1 CARTONINJECTION107
42192-614-10PHENYTOIN SODIUM2 mL in 1 VIALINJECTION27
42192-614-30PHENYTOIN SODIUM10 in 1 CARTONINJECTION107
42192-614-30PHENYTOIN SODIUM5 mL in 1 VIALINJECTION57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-614-10ML - Milliliter42192-6149c29d896-1b61-47e7-b17e-50f740739cb112022-01-06
42192-614-30ML - Milliliter42192-61417a7423d-7d1a-4126-b3c2-788353efc0b012022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-614PHENYTOIN SODIUM INJECTION [ACELLA PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 4 package rows20240918_6922f32f-8bed-4c09-8103-27987bcbd104.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670351phenytoin sodium 100 MG in 2 ML InjectionPSN6922f32f-8bed-4c09-8103-27987bcbd1047
1670353phenytoin sodium 250 MG in 5 ML InjectionPSN6922f32f-8bed-4c09-8103-27987bcbd1047
16703512 ML phenytoin sodium 50 MG/ML InjectionSCD6922f32f-8bed-4c09-8103-27987bcbd1047
16703535 ML phenytoin sodium 50 MG/ML InjectionSCD6922f32f-8bed-4c09-8103-27987bcbd1047
16703512 ML DPH sodium 50 MG/ML InjectionSY6922f32f-8bed-4c09-8103-27987bcbd1047
16703535 ML DPH sodium 50 MG/ML InjectionSY6922f32f-8bed-4c09-8103-27987bcbd1047
1670351phenytoin sodium 100 MG per 2 ML InjectionSY6922f32f-8bed-4c09-8103-27987bcbd1047
1670353phenytoin sodium 250 MG per 5 ML InjectionSY6922f32f-8bed-4c09-8103-27987bcbd1047

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-614-034219206140325 VIAL in 1 CARTON (42192-614-03) > 2 mL in 1 VIAL25 vial2021-12-300000-00-00NoNoCurrent
42192-614-064219206140625 VIAL in 1 CARTON (42192-614-06) > 5 mL in 1 VIAL25 vial2021-12-300000-00-00NoNoCurrent
42192-614-104219206141010 VIAL in 1 CARTON (42192-614-10) / 2 mL in 1 VIAL10 vial2021-12-300000-00-00NoNoCurrent
42192-614-304219206143010 VIAL in 1 CARTON (42192-614-30) / 5 mL in 1 VIAL10 vial2021-12-300000-00-00NoNoCurrent