Prescription drug · ANDA
Lamotrigine NDC 76420-182
Lamotrigine 200 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-182-60 | 76420018260 | 60 TABLET in 1 BOTTLE, PLASTIC (76420-182-60)Marketed from Oct 14, 2020 |
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 — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090170
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 76420-182_b19b2211-34a8-759d-e053-2a95a90af002SPL ID b19b2211-34a8-759d-e053-2a95a90af002SPL set ID 8ac9dc83-edb2-4ae5-8064-40f113fd3aabRxCUI 198429UNII 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
N476420018260followed by a unit qualifier and the quantityPackage 76420-0182-60. 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 tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic 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: T…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090170
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 | Coupler LLC | 67046-0359 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1978 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-114 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-111 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-112 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-113 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Coupler LLC | 67046-0358 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7223 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2343 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-2131 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-2129 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-2130 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1110 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7544 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2406 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0289 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Coupler LLC | 67046-0749 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-719 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1479 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1179 |
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