Prescription drug · NDA
Subvenite (Lamotrigine) NDC 69102-418
Lamotrigine 10 mg/mL · Suspension · Oral · OWP Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69102-418-01 | 6910204180169102041801 | 1 BOTTLE in 1 PACKAGE (69102-418-01) / 240 mL in 1 BOTTLEMarketed from Oct 1, 2025 | |
| 69102-418-02 | 6910204180269102041802 | 2 BOTTLE in 1 PACKAGE (69102-418-02) / 240 mL in 1 BOTTLEMarketed from Oct 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Subvenite
- Generic name (nonproprietary)
- lamotrigine
- Active ingredients
- Lamotrigine — 10 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- OWP Pharmaceuticals, Inc.NDC labeler code 69102
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218879
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 69102-418_3e1f8823-3330-41e3-a385-3f65d45a1bcaSPL ID 3e1f8823-3330-41e3-a385-3f65d45a1bcaSPL set ID 022b0913-f683-4af8-a862-f81b315909b2RxCUI 2724462, 2724466UNII U3H27498KSUPC 0369102418015
- Pharmacologic class
- Anti-epileptic Agent; Mood Stabilizer
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469102041801followed by a unit qualifier and the quantityPackage 69102-0418-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
SUBVENITE is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: partial-onset seizures primary generalized tonic-clonic (PGTC) seizures generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. ( 1.1 ) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. ( 1.2 ) Limitations of Use: Treatment…
Excerpt only. Read the full label for complete information.
About NDC 69102-418
- What is NDC 69102-418?
- 69102-418 is the product NDC for Subvenite (lamotrigine), Lamotrigine 10 mg/mL suspension, listed with the FDA by OWP Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Subvenite (Lamotrigine).
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- OWP Pharmaceuticals, Inc., NDC labeler code 69102. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Subvenite?
- 7 other product NDCs are listed under this name. See all Subvenite NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Subvenite products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Subvenitelamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-300 | 69102-0300-01 |
| Subvenitelamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-306 | 69102-0306-01 |
| Subvenitelamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-312 | 69102-0312-01 |
| Subvenitelamotrigine | Lamotrigine 150 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-150 | 69102-0150-06 |
| Subvenitelamotrigine | Lamotrigine 25 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-301 | 69102-0301-0169102-0301-02 |
| Subvenitelamotrigine | Lamotrigine 100 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-319 | 69102-0319-0169102-0319-02 |
| Subvenitelamotrigine | Lamotrigine 200 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-320 | 69102-0320-01 |