FDA.reportPublic FDA data

SUBVENITE

Product NDC
69102-301
11-digit product format
691020301
Labeler code
69102
Product ID
69102-301_15cf4680-04a8-421c-a475-cd753b58b604
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
TABLET
Route
ORAL
Labeler
OWP Pharmaceuticals, Inc.
Application
ANDA078947
Marketing category
ANDA
Marketing start
2018-03-10
Substance
LAMOTRIGINE
Active strength
25 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SUBVENITE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3H27498KS
Rxcui198427, 198428, 198429, 282401, 751139, 751563, 753451, 2001506, 2001508, 2003796, 2003797, 2003798, 2003799, 2003801

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69102-301-012024-04-11C16284748780-11030e364-fac4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
69102-301-012024-04-11C16284748780-11030e364-fac4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
69102-301-022024-04-11C16284748780-11030e364-fac4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
69102-301-022024-04-11C16284748780-11030e364-fac4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
69102-301-012024-01-30C16284748780-11030e364-fac4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
69102-301-012024-01-30C16284748780-11030e364-fac4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
69102-301-022024-01-30C16284748780-11030e364-fac4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994
69102-301-022024-01-30C16284748780-11030e364-fac4-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SUBVENITE safely and effectively. See full prescribing information for SUBVENITE. SUBVENITE (lamotrigine) tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69102-301-01SUBVENITE100 in 1 BOTTLETABLET10015
69102-301-02SUBVENITE6600 in 1 BOTTLETABLET660015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69102-301-01EA - Each69102-3017206119c-2e6e-45b3-ac8b-eecfab1bb3ef12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69102-301SUBVENITE (LAMOTRIGINE) TABLET SUBVENITE (LAMOTRIGINE) KIT [OWP PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 2 package rows20250102_7ad18b68-ba16-4810-9c3e-27fa970454e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003797{14 (lamotrigine 100 MG Oral Tablet [Subvenite]) / 84 (lamotrigine 25 MG Oral Tablet [Subvenite]) } Pack [Subvenite Green (for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate)]BPCK7ad18b68-ba16-4810-9c3e-27fa970454e815
2003799{35 (lamotrigine 25 MG Oral Tablet [Subvenite]) } Pack [Subvenite Blue (for Patients Taking Valproate)]BPCK7ad18b68-ba16-4810-9c3e-27fa970454e815
2003798{7 (lamotrigine 100 MG Oral Tablet [Subvenite]) / 42 (lamotrigine 25 MG Oral Tablet [Subvenite]) } Pack [Subvenite Orange (for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)]BPCK7ad18b68-ba16-4810-9c3e-27fa970454e815
753451{14 (lamotrigine 100 MG Oral Tablet) / 84 (lamotrigine 25 MG Oral Tablet) } PackGPCK7ad18b68-ba16-4810-9c3e-27fa970454e815
751139{35 (lamotrigine 25 MG Oral Tablet) } PackGPCK7ad18b68-ba16-4810-9c3e-27fa970454e815
751563{7 (lamotrigine 100 MG Oral Tablet) / 42 (lamotrigine 25 MG Oral Tablet) } PackGPCK7ad18b68-ba16-4810-9c3e-27fa970454e815
198427lamoTRIgine 100 MG Oral TabletPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
198428lamoTRIgine 150 MG Oral TabletPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
198429lamoTRIgine 200 MG Oral TabletPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
751563lamoTRIgine 25 MG (42), 100 MG (7) Oral Tablet 49 Count PackPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
753451lamoTRIgine 25 MG (84), 100 MG (14) Oral Tablet 98 Count PackPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
282401lamoTRIgine 25 MG Oral TabletPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
751139lamoTRIgine 25 MG Oral Tablet 35 Count PackPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
2003796Subvenite 100 MG Oral TabletPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
2001506Subvenite 150 MG Oral TabletPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
2003801Subvenite 200 MG Oral TabletPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
2001508Subvenite 25 MG Oral TabletPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
2003799Subvenite Starter Kit Blue 25 MG 35 CountPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
2003797Subvenite Starter Kit Green 25 MG (84), 100 MG (14) 98 CountPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
2003798Subvenite Starter Kit Orange 25 MG (42), 100 MG (7) 49 CountPSN7ad18b68-ba16-4810-9c3e-27fa970454e815
2003796lamotrigine 100 MG Oral Tablet [Subvenite]SBD7ad18b68-ba16-4810-9c3e-27fa970454e815
2001506lamotrigine 150 MG Oral Tablet [Subvenite]SBD7ad18b68-ba16-4810-9c3e-27fa970454e815
2003801lamotrigine 200 MG Oral Tablet [Subvenite]SBD7ad18b68-ba16-4810-9c3e-27fa970454e815
2001508lamotrigine 25 MG Oral Tablet [Subvenite]SBD7ad18b68-ba16-4810-9c3e-27fa970454e815
198427lamotrigine 100 MG Oral TabletSCD7ad18b68-ba16-4810-9c3e-27fa970454e815
198428lamotrigine 150 MG Oral TabletSCD7ad18b68-ba16-4810-9c3e-27fa970454e815
198429lamotrigine 200 MG Oral TabletSCD7ad18b68-ba16-4810-9c3e-27fa970454e815
282401lamotrigine 25 MG Oral TabletSCD7ad18b68-ba16-4810-9c3e-27fa970454e815
751139lamotrigine Blue (For Patients Taking Valproate)SY7ad18b68-ba16-4810-9c3e-27fa970454e815
753451lamotrigine Green (For Patients Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Rifampin and Not Taking Valproate)SY7ad18b68-ba16-4810-9c3e-27fa970454e815
751563lamotrigine Orange (USP Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)SY7ad18b68-ba16-4810-9c3e-27fa970454e815
2003796Subvenite 100 MG Oral TabletSY7ad18b68-ba16-4810-9c3e-27fa970454e815
2001506Subvenite 150 MG Oral TabletSY7ad18b68-ba16-4810-9c3e-27fa970454e815
2003801Subvenite 200 MG Oral TabletSY7ad18b68-ba16-4810-9c3e-27fa970454e815
2001508Subvenite 25 MG Oral TabletSY7ad18b68-ba16-4810-9c3e-27fa970454e815
2003799Subvenite Blue Kit (for Patients Taking Valproate)SY7ad18b68-ba16-4810-9c3e-27fa970454e815
2003797Subvenite Green Kit (for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate)SY7ad18b68-ba16-4810-9c3e-27fa970454e815
2003798Subvenite Orange Kit (for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate)SY7ad18b68-ba16-4810-9c3e-27fa970454e815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69102-301-0169102030101100 TABLET in 1 BOTTLE (69102-301-01) 100 tablet2018-03-100000-00-00NoNoCurrent
69102-301-02691020301026600 TABLET in 1 BOTTLE (69102-301-02) 6600 tablet2018-03-100000-00-00NoNoCurrent