SUBVENITE

Product NDC
69102-418
11-digit product format
691020418
Labeler code
69102
Product ID
69102-418_3e1f8823-3330-41e3-a385-3f65d45a1bca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LAMOTRIGINE
Dosage form
SUSPENSION
Route
ORAL
Labeler
OWP Pharmaceuticals, Inc.
Application
NDA218879
Marketing category
NDA
Marketing start
2025-10-01
Substance
LAMOTRIGINE
Active strength
10 mg/mL
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N218879-001SUBVENITELAMOTRIGINE10MG/MLSUSPENSION / ORALRLD, RS2025-09-16

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218879-001115966342040-05-29U-42712025-09-26
N218879-001115966342040-05-29U-42722025-09-26
N218879-001115966342040-05-29U-42732025-09-26
N218879-001116125662040-05-29U-42712025-09-26
N218879-001116125662040-05-29U-42722025-09-26
N218879-001116125662040-05-29U-42732025-09-26
N218879-001126293772040-05-29U-4539Drug product2026-06-18
N218879-001126293772040-05-29U-4540Drug product2026-06-18
N218879-001126293772040-05-29U-4541Drug product2026-06-18
N218879-001126362892040-05-29Drug product2026-06-18

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N218879-001SUBVENITE10MG/MLSUSPENSION / ORALRLD, RS2025-09-1684e616aacf4f…
2026-08-18 06:07:402026-07N218879-001SUBVENITE10MG/MLSUSPENSION / ORALRLD, RS2025-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218879-001SUBVENITE10MG/MLSUSPENSION / ORALRLD, RS2025-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218879-001SUBVENITE10MG/MLSUSPENSION / ORALRLD, RS2025-09-1631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218879-001SUBVENITE10MG/MLSUSPENSION / ORALRLD, RS2025-09-16a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218879-001115966342040-05-29U-42712025-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N218879-001115966342040-05-29U-42722025-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N218879-001115966342040-05-29U-42732025-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N218879-001116125662040-05-29U-42712025-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N218879-001116125662040-05-29U-42722025-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N218879-001116125662040-05-29U-42732025-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N218879-001126293772040-05-29U-4539Drug product2026-06-1884e616aacf4f…
2026-09-14 22:38:342026-08N218879-001126293772040-05-29U-4540Drug product2026-06-1884e616aacf4f…
2026-09-14 22:38:342026-08N218879-001126293772040-05-29U-4541Drug product2026-06-1884e616aacf4f…
2026-09-14 22:38:342026-08N218879-001126362892040-05-29Drug product2026-06-1884e616aacf4f…
2026-08-18 06:07:402026-07N218879-001115966342040-05-29U-42712025-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N218879-001115966342040-05-29U-42722025-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N218879-001115966342040-05-29U-42732025-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N218879-001116125662040-05-29U-42712025-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N218879-001116125662040-05-29U-42722025-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N218879-001116125662040-05-29U-42732025-09-26caaa826d4ba7…
2026-08-18 06:07:402026-07N218879-001126293772040-05-29U-4539Drug product2026-06-18caaa826d4ba7…
2026-08-18 06:07:402026-07N218879-001126293772040-05-29U-4540Drug product2026-06-18caaa826d4ba7…
2026-08-18 06:07:402026-07N218879-001126293772040-05-29U-4541Drug product2026-06-18caaa826d4ba7…
2026-08-18 06:07:402026-07N218879-001126362892040-05-29Drug product2026-06-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218879-001115966342040-05-29U-42712025-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218879-001115966342040-05-29U-42722025-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218879-001115966342040-05-29U-42732025-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218879-001116125662040-05-29U-42712025-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218879-001116125662040-05-29U-42722025-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218879-001116125662040-05-29U-42732025-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218879-001115966342040-05-29U-42712025-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218879-001115966342040-05-29U-42722025-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218879-001115966342040-05-29U-42732025-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218879-001116125662040-05-29U-42712025-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218879-001116125662040-05-29U-42722025-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218879-001116125662040-05-29U-42732025-09-2631067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218879-001115966342040-05-29U-42712025-09-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218879-001115966342040-05-29U-42722025-09-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218879-001115966342040-05-29U-42732025-09-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218879-001116125662040-05-29U-42712025-09-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218879-001116125662040-05-29U-42722025-09-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218879-001116125662040-05-29U-42732025-09-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218879-001126293772040-05-29U-4539Drug product2026-06-18a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218879-001126293772040-05-29U-4540Drug product2026-06-18a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LAMOTRIGINE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3H27498KSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2724462Internal RxNorm lookup
2724466Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
022b0913-f683-4af8-a862-f81b315909b2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
14a9502b-3d70-0496-a7e1-b16edaa005b8Product name520250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0Product name720250401
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69102-418-01ML - Milliliter69102-418f90c9bcf-ae38-4795-b7f3-04d9c90658ea12025-12-16
69102-418-02ML - Milliliter69102-418ac3dd3b6-fdca-4851-81c0-9f024ab4d53412025-10-14

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUBVENITELAMOTRIGINEOWP Pharmaceuticals, Inc.022b0913-f683-4af8-a862-f81b315909b22026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 218879
application number: NDA218879
ndc (product): 69102-418

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2724462lamoTRIgine 10 MG/mL Oral SuspensionPSN022b0913-f683-4af8-a862-f81b315909b22
2724466Subvenite 10 MG/mL Oral SuspensionPSN022b0913-f683-4af8-a862-f81b315909b22
2724466lamotrigine 10 MG/ML Oral Suspension [Subvenite]SBD022b0913-f683-4af8-a862-f81b315909b22
2724462lamotrigine 10 MG/ML Oral SuspensionSCD022b0913-f683-4af8-a862-f81b315909b22
2724466Subvenite 10 MG/ML Oral SuspensionSY022b0913-f683-4af8-a862-f81b315909b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69102-418-01691020418011 BOTTLE in 1 PACKAGE (69102-418-01) / 240 mL in 1 BOTTLE1 bottle2025-10-01NoNoCurrent
69102-418-02691020418022 BOTTLE in 1 PACKAGE (69102-418-02) / 240 mL in 1 BOTTLE2 bottle2025-10-01NoNoCurrent