Prescription drug · ANDA
Lamotrigine ER NDC 72189-467
Lamotrigine 200 mg/1 · Tablet, Extended release · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-467-30 | 7218904673072189046730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-467-30)Marketed from May 3, 2023 |
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 ER
- Generic name (nonproprietary)
- lamotrigine er
- Active ingredients
- Lamotrigine — 200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- 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 72189-467_2c4ddaed-38a0-7cd7-e063-6294a90a148fSPL ID 2c4ddaed-38a0-7cd7-e063-6294a90a148fSPL set ID faccacb7-65f1-cb00-e053-6394a90a9fcbRxCUI 900156UNII 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
N472189046730followed by a unit qualifier and the quantityPackage 72189-0467-30. 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)
1.1 Adjunctive Therapy Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. 1.2 Monotherapy Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of lamotrigine extended-release have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.3 Limitation of Use Sa…
Excerpt only. Read the full label for complete information.
About NDC 72189-467
- What is NDC 72189-467?
- 72189-467 is the product NDC for Lamotrigine ER, Lamotrigine 200 mg/1 tablet, extended release, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamotrigine ER.
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. 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 ER?
- 1 other product NDC are listed under this name. See all Lamotrigine ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lamotrigine ER 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 ER | Lamotrigine 200 mg/1 | Tablet, Film coated, Extended releaseOral | Direct_rx | 72189-560 | 72189-0560-30 |
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 |
|---|---|---|---|---|
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-979 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-982 |
| 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 |
| Lamotriginelamotirigine | Lamotrigine 100 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1516 |
| Lamotriginelamotirigine | Lamotrigine 25 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1514 |
| 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 |