FDA.reportPublic FDA data

Phenytoin

Product NDC
17856-4070
11-digit product format
178564070
Labeler code
17856
Product ID
17856-4070_36335944-2d3c-b82e-e063-6294a90a705c
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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6158TKW0C5
Rxcui1313112

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-4070-12024-05-09C16284748780-11030e365-660b-111a-e063-dadaa90a10e2PHENYTOIN ORAL SUSPENSION These highlights do not include all the information needed to use PHENYTOIN ORAL SUSPENSION safely and effectively. See full prescribing information for PHENYTOIN ORAL SUSPENSION. PHENYTOIN oral suspension Initial U.S. Approval: 1953
17856-4070-12024-01-30C16284748780-11030e365-660b-111a-e063-dadaa90a10e2PHENYTOIN ORAL SUSPENSION These highlights do not include all the information needed to use PHENYTOIN ORAL SUSPENSION safely and effectively. See full prescribing information for PHENYTOIN ORAL SUSPENSION. PHENYTOIN oral suspension Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-4070-1Phenytoin72 in 1 BOX, UNIT-DOSESUSPENSION725
17856-4070-2Phenytoin4 mL in 1 CUP, UNIT-DOSESUSPENSION45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-4070-1ML - Milliliter17856-407031c2fda1-c530-4268-a9b7-f67ad79488e112025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-4070PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 2 package rows20240510_09daf485-3355-44cb-92af-072dd281e129.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSN09daf485-3355-44cb-92af-072dd281e1295
1313112phenytoin 25 MG/ML Oral SuspensionSCD09daf485-3355-44cb-92af-072dd281e1295
1313112DPH 25 MG/ML Oral SuspensionSY09daf485-3355-44cb-92af-072dd281e1295
1313112phenytoin 100 MG per 4 ML Oral SuspensionSY09daf485-3355-44cb-92af-072dd281e1295
1313112phenytoin 125 MG per 5 ML Oral SuspensionSY09daf485-3355-44cb-92af-072dd281e1295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-4070-11785640700172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-4070-1) / 4 mL in 1 CUP, UNIT-DOSE (17856-4070-2) 2024-05-090000-00-00NoNoCurrent
17856-4070-2178564070024 mL in 1 CUP, UNIT-DOSE4 mlHistorical