Home NDC 69102-418 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218879-001 SUBVENITE LAMOTRIGINE 10MG/ML SUSPENSION / ORAL RLD, RS 2025-09-16
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218879-001 11596634 2040-05-29 U-4271 2025-09-26 N218879-001 11596634 2040-05-29 U-4272 2025-09-26 N218879-001 11596634 2040-05-29 U-4273 2025-09-26 N218879-001 11612566 2040-05-29 U-4271 2025-09-26 N218879-001 11612566 2040-05-29 U-4272 2025-09-26 N218879-001 11612566 2040-05-29 U-4273 2025-09-26 N218879-001 12629377 2040-05-29 U-4539 Drug product 2026-06-18 N218879-001 12629377 2040-05-29 U-4540 Drug product 2026-06-18 N218879-001 12629377 2040-05-29 U-4541 Drug product 2026-06-18 N218879-001 12636289 2040-05-29 Drug product 2026-06-18
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N218879-001 SUBVENITE 10MG/ML SUSPENSION / ORAL RLD, RS 2025-09-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218879-001 SUBVENITE 10MG/ML SUSPENSION / ORAL RLD, RS 2025-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218879-001 SUBVENITE 10MG/ML SUSPENSION / ORAL RLD, RS 2025-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218879-001 SUBVENITE 10MG/ML SUSPENSION / ORAL RLD, RS 2025-09-16 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218879-001 SUBVENITE 10MG/ML SUSPENSION / ORAL RLD, RS 2025-09-16 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N218879-001 11596634 2040-05-29 U-4271 2025-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218879-001 11596634 2040-05-29 U-4272 2025-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218879-001 11596634 2040-05-29 U-4273 2025-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218879-001 11612566 2040-05-29 U-4271 2025-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218879-001 11612566 2040-05-29 U-4272 2025-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218879-001 11612566 2040-05-29 U-4273 2025-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218879-001 12629377 2040-05-29 U-4539 Drug product 2026-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218879-001 12629377 2040-05-29 U-4540 Drug product 2026-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218879-001 12629377 2040-05-29 U-4541 Drug product 2026-06-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218879-001 12636289 2040-05-29 Drug product 2026-06-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218879-001 11596634 2040-05-29 U-4271 2025-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218879-001 11596634 2040-05-29 U-4272 2025-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218879-001 11596634 2040-05-29 U-4273 2025-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218879-001 11612566 2040-05-29 U-4271 2025-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218879-001 11612566 2040-05-29 U-4272 2025-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218879-001 11612566 2040-05-29 U-4273 2025-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218879-001 12629377 2040-05-29 U-4539 Drug product 2026-06-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218879-001 12629377 2040-05-29 U-4540 Drug product 2026-06-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218879-001 12629377 2040-05-29 U-4541 Drug product 2026-06-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218879-001 12636289 2040-05-29 Drug product 2026-06-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218879-001 11596634 2040-05-29 U-4271 2025-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218879-001 11596634 2040-05-29 U-4272 2025-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218879-001 11596634 2040-05-29 U-4273 2025-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218879-001 11612566 2040-05-29 U-4271 2025-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218879-001 11612566 2040-05-29 U-4272 2025-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218879-001 11612566 2040-05-29 U-4273 2025-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218879-001 11596634 2040-05-29 U-4271 2025-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218879-001 11596634 2040-05-29 U-4272 2025-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218879-001 11596634 2040-05-29 U-4273 2025-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218879-001 11612566 2040-05-29 U-4271 2025-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218879-001 11612566 2040-05-29 U-4272 2025-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218879-001 11612566 2040-05-29 U-4273 2025-09-26 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218879-001 11596634 2040-05-29 U-4271 2025-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218879-001 11596634 2040-05-29 U-4272 2025-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218879-001 11596634 2040-05-29 U-4273 2025-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218879-001 11612566 2040-05-29 U-4271 2025-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218879-001 11612566 2040-05-29 U-4272 2025-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218879-001 11612566 2040-05-29 U-4273 2025-09-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218879-001 12629377 2040-05-29 U-4539 Drug product 2026-06-18 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218879-001 12629377 2040-05-29 U-4540 Drug product 2026-06-18 a50c72e98297…
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 Ingredient Strength LAMOTRIGINE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3H27498KS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2724462 Internal RxNorm lookup 2724466 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69102-418-01 69102041801 1 BOTTLE in 1 PACKAGE (69102-418-01) / 240 mL in 1 BOTTLE 1 bottle 2025-10-01 No No Current 69102-418-02 69102041802 2 BOTTLE in 1 PACKAGE (69102-418-02) / 240 mL in 1 BOTTLE 2 bottle 2025-10-01 No No Current