Prescription drug · ANDA
Lamotrigine (Lamotirigine) NDC 70771-1514
Lamotrigine 25 mg/1 · Tablet, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70771-1514Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1514Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1514-3 | 70771151403 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1514-3)Marketed from May 14, 2020 | |
| 70771-1514-4 | 70771151404 | 10 BLISTER PACK in 1 CARTON (70771-1514-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1514-2)Marketed from May 14, 2020 | |
| 70771-1514-5 | 70771151405 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1514-5)Marketed from May 14, 2020 | |
| 70771-1514-9 | 70771151409 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1514-9)Marketed from May 14, 2020 |
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)
- lamotirigine
- Active ingredients
- Lamotrigine — 25 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207763
- 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 70771-1514_c2007dd5-98b7-47e2-8354-7ce432174a48SPL ID c2007dd5-98b7-47e2-8354-7ce432174a48SPL set ID ecb7a528-699f-4e51-9887-dee60456da2fRxCUI 850087, 850091, 900156, 900164, 1098608, 1146690UNII U3H27498KS
- 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
N470771151403followed by a unit qualifier and the quantityPackage 70771-1514-03. 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 .
About NDC 70771-1514
- What is NDC 70771-1514?
- 70771-1514 is the product NDC for Lamotrigine (lamotirigine), Lamotrigine 25 mg/1 tablet, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamotrigine (Lamotirigine).
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 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 Limited | 46708-773 | 46708-0773-1046708-0773-30 |
Other NDCs under ANDA 207763
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 |
|---|---|---|---|---|
| Lamotriginelamotirigine | Lamotrigine 100 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1516 |
| Lamotriginelamotirigine | Lamotrigine 50 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1515 |
| Lamotriginelamotirigine | Lamotrigine 200 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1517 |
| Lamotriginelamotirigine | Lamotrigine 250 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1518 |
| Lamotriginelamotirigine | Lamotrigine 300 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1519 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4702 |
| Lamotrigine ER | Lamotrigine 200 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-467 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-982 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-979 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-980 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-981 |
| Lamotrigine | Lamotrigine 250 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-983 |
| Lamotrigine | Lamotrigine 300 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-984 |