Prescription drug · ANDA
Lamotrigine NDC 72888-027
Lamotrigine 150 mg/1 · Tablet · Oral · Advagen Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-027-05 | 72888002705 | 500 TABLET in 1 BOTTLE (72888-027-05)Marketed from Oct 29, 2021 | |
| 72888-027-60 | 72888002760 | 60 TABLET in 1 BOTTLE (72888-027-60)Marketed from Oct 29, 2021 |
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 — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advagen Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078625
- 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 72888-027_43efd790-7e05-d37a-e063-6294a90a4156SPL ID 43efd790-7e05-d37a-e063-6294a90a4156SPL set ID 4ca9d713-ab63-48bf-9386-29301a842e60RxCUI 198427, 198428, 198429, 282401UNII U3H27498KSUPC 0372888026008, 0372888028606, 0372888025056, 0372888027050, 0372888026053, 0372888025018, 0372888026015, 0372888027609, 0372888025001, 0372888028057
- 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
N472888002705followed by a unit qualifier and the quantityPackage 72888-0027-05. 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: Tr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078625
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 | TabletOral | Advagen Pharma Limited | 72888-025 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Advagen Pharma Limited | 72888-026 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Advagen Pharma Limited | 72888-028 |