Prescription drug · ANDA
Subvenite (Lamotrigine) NDC 69102-150
Lamotrigine 150 mg/1 · Tablet · Oral · OWP Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69102-150-06 | 6910201500669102015006 | 100 TABLET in 1 BOTTLE (69102-150-06)Marketed from Mar 10, 2018 |
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 — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- OWP Pharmaceuticals, Inc.NDC labeler code 69102
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078947
- 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 69102-150_15cf4680-04a8-421c-a475-cd753b58b604SPL ID 15cf4680-04a8-421c-a475-cd753b58b604SPL set ID 7ad18b68-ba16-4810-9c3e-27fa970454e8RxCUI 198427, 198428, 198429, 282401, 751139, 751563, 753451, 2001506, 2001508, 2003796, 2003797, 2003798, 2003799, 2003801UNII U3H27498KSUPC 0369102150069, 0369102319015, 0369102320011, 0369102301010
- 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
N469102015006followed by a unit qualifier and the quantityPackage 69102-0150-06. 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: Treatme…
Excerpt only. Read the full label for complete information.
About NDC 69102-150
- What is NDC 69102-150?
- 69102-150 is the product NDC for Subvenite (lamotrigine), Lamotrigine 150 mg/1 tablet, listed with the FDA by OWP Pharmaceuticals, Inc.. It has 1 package NDC, 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 | Lamotrigine 10 mg/mL | SuspensionOral | OWP Pharmaceuticals, Inc. | 69102-418 | 69102-0418-0169102-0418-02 |
| 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 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 |
Other NDCs under ANDA 078947
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-045 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-047 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-048 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-049 |
| Lamotrigine | — | Kit | Torrent Pharmaceuticals Limited | 13668-266 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-203 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-238 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-6028 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-855 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3607 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-639 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2755 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2889 |
| LAMOTRIGINE Kitlamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-137 |
| LAMOTRIGINE Kitlamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-359 |
| Subvenitelamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-300 |
| Subvenitelamotrigine | Lamotrigine 25 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-301 |
| Subvenitelamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-306 |
| Subvenitelamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-312 |
| Subvenitelamotrigine | Lamotrigine 100 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-319 |
Showing 20 of 21.