Prescription drug · ANDA
LAMOTRIGINE Kit (lamotrigine) NDC 69102-359
Kit · OWP Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69102-359-11 | 69102035911 | 14 BLISTER PACK in 1 PACKAGE, COMBINATION (69102-359-11) / 1 KIT in 1 BLISTER PACKMarketed from Aug 30, 2017 |
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)
- LAMOTRIGINE KitSuffix: Kit
- Generic name (nonproprietary)
- lamotrigine
- Dosage form
- Kit
- Labeler
- OWP Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078947
- Marketing start
- Listing expires
- Identifiers
- Product ID 69102-359_14718eaf-e725-48ef-b2f8-1bd20b3a7cbaSPL ID 14718eaf-e725-48ef-b2f8-1bd20b3a7cbaSPL set ID 474fb321-575c-4b97-9dbe-080061652ee4RxCUI 198427, 282401, 751139, 751563, 753451UNII U3H27498KS
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N469102035911followed by a unit qualifier and the quantityPackage 69102-0359-11. 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)
Lamotrigine tablet 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…
Excerpt only. Read the full label for complete information.
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 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3607 |
| Lamotrigine | — | Kit | Torrent Pharmaceuticals Limited | 13668-266 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-6028 |
| 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 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2755 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-855 |
| LAMOTRIGINE Kitlamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-137 |
| Subvenitelamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-306 |
| Subvenitelamotrigine | Lamotrigine 150 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-150 |
| Subvenitelamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-300 |
| Subvenitelamotrigine | Lamotrigine 25 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-301 |
| Subvenitelamotrigine | Lamotrigine 200 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-320 |
| Subvenitelamotrigine | — | Kit | OWP Pharmaceuticals, Inc. | 69102-312 |
| Subvenitelamotrigine | Lamotrigine 100 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-319 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-047 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-045 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | OWP Pharmaceuticals, Inc. | 69102-639 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-048 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-049 |
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