Prescription drug · ANDA
Lamotrigine NDC 13668-695
Lamotrigine 100 mg/1 · Tablet, Orally disintegrating · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-695-01 | 13668069501 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-695-01)Marketed from Jan 8, 2026 | |
| 13668-695-30 | 13668069530 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-695-30)Marketed from Jan 8, 2026 | |
| 13668-695-72 | 13668069572 | 30 BLISTER PACK in 1 CARTON (13668-695-72) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (13668-695-71)Marketed from Jan 8, 2026 |
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
- Generic name (nonproprietary)
- lamotrigine
- Active ingredients
- Lamotrigine — 100 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217100
- 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 13668-695_1b3ee868-07fa-4918-a4e4-4a4730d19485SPL ID 1b3ee868-07fa-4918-a4e4-4a4730d19485SPL set ID 22225cc4-028e-43ad-8e1f-dcebdc244ecbRxCUI 103968, 198430, 252478, 252479UNII U3H27498KSUPC 0313668696301, 0313668694307, 0313668695304, 0313668693300
- 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
N413668069501followed by a unit qualifier and the quantityPackage 13668-0695-01. 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)
Lamotrigine orally disintegrating tablets are 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. ( …
Excerpt only. Read the full label for complete information.
About NDC 13668-695
- What is NDC 13668-695?
- 13668-695 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, orally disintegrating, listed with the FDA by Torrent Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamotrigine.
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lamotrigine?
- 261 other product NDCs are listed under this name. See all Lamotrigine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lamotrigine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4702 | 70518-4702-00 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Coupler LLC | 67046-0358 | 67046-0358-03 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Coupler LLC | 67046-0749 | 67046-0749-03 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Coupler LLC | 67046-0359 | 67046-0359-03 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4638 | 70518-4638-00 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-773 | 62332-0773-1062332-0773-30 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-772 | 46708-0772-1046708-0772-30 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-770 | 46708-0770-1546708-0770-30 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-771 | 46708-0771-1546708-0771-30 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-773 | 46708-0773-1046708-0773-30 |
Other NDCs under ANDA 217100
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 50 mg/1 | Tablet, Orally disintegratingOral | Torrent Pharmaceuticals Limited | 13668-694 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | Torrent Pharmaceuticals Limited | 13668-693 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Orally disintegratingOral | Torrent Pharmaceuticals Limited | 13668-696 |