Prescription drug · ANDA
lamotrigine (Lamotrigine extended-release) NDC 70518-4442
Lamotrigine 50 mg/1 · Tablet, Film coated, Extended release · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70518-4442Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4442Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4442-0 | 7051844420070518444200 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4442-0)Marketed from Aug 14, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 extended-release
- Active ingredients
- Lamotrigine — 50 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213949
- 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 70518-4442_5b3510b0-ec43-6767-e063-6294a90a36daSPL ID 5b3510b0-ec43-6767-e063-6294a90a36da
- 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
N470518444200followed by a unit qualifier and the quantityPackage 70518-4442-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-4442
- What is NDC 70518-4442?
- 70518-4442 is the product NDC for lamotrigine (lamotrigine extended-release), Lamotrigine 50 mg/1 tablet, film coated, extended release, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- lamotrigine (Lamotrigine extended-release).
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 262 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 25 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-770 | 62332-0770-1562332-0770-30 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-771 | 62332-0771-1562332-0771-30 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-772 | 62332-0772-1062332-0772-30 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-773 | 62332-0773-1062332-0773-30 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-770 | 46708-0770-1546708-0770-30 |
Other NDCs under ANDA 213949
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 |
|---|---|---|---|---|
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4638 |
| Lamotrigine ER | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_rx | 72189-560 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 82804-022 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0047 |
| lamotriginelamotrigine extended-release | Lamotrigine 25 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0044 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0045 |
| lamotriginelamotrigine extended-release | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0046 |
| lamotriginelamotrigine extended-release | Lamotrigine 250 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0048 |
| lamotriginelamotrigine extended-release | Lamotrigine 300 mg/1 | Tablet, Film coated, Extended releaseOral | Yiling Pharmaceutical, Inc. | 69117-0049 |
| lamotriginelamotrigine extended-release | Lamotrigine 50 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-241 |
| lamotriginelamotrigine extended-release | Lamotrigine 25 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-240 |
| lamotriginelamotrigine extended-release | Lamotrigine 300 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-245 |
| lamotriginelamotrigine extended-release | Lamotrigine 100 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-242 |
| lamotriginelamotrigine extended-release | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-243 |
| lamotriginelamotrigine extended-release | Lamotrigine 250 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals Inc | 31722-244 |