Prescription drug · ANDA
Lamotrigine NDC 71205-245
Lamotrigine 100 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-245-30 | 71205024530 | 30 TABLET in 1 BOTTLE, PLASTIC (71205-245-30)Marketed from Apr 1, 2019 | |
| 71205-245-60 | 71205024560 | 60 TABLET in 1 BOTTLE, PLASTIC (71205-245-60)Marketed from Apr 1, 2019 | |
| 71205-245-90 | 71205024590 | 90 TABLET in 1 BOTTLE, PLASTIC (71205-245-90)Marketed from Apr 1, 2019 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- 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)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-245_df5002ba-15f4-4e47-8d2e-1ce041c26944SPL ID df5002ba-15f4-4e47-8d2e-1ce041c26944SPL set ID 52273d60-3f27-4846-bf40-014ebcf09417RxCUI 198427UNII U3H27498KSUPC 0371205245306
- 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
N471205024530followed by a unit qualifier and the quantityPackage 71205-0245-30. 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)
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 AED. ( 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: Treatment …
Excerpt only. Read the full label for complete information.
About NDC 71205-245
- What is NDC 71205-245?
- 71205-245 is the product NDC for Lamotrigine, Lamotrigine 100 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamotrigine.
- What is the active ingredient?
- Lamotrigine.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. 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?
- 259 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 Limited | 46708-770 | 46708-0770-1546708-0770-30 |
| Lamotrigine | Lamotrigine 50 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-771 | 46708-0771-1546708-0771-30 |
| Lamotrigine | Lamotrigine 100 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-772 | 46708-0772-1046708-0772-30 |
| Lamotrigine | Lamotrigine 200 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-773 | 46708-0773-1046708-0773-30 |
| Lamotrigine | Lamotrigine 25 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Inc. | 62332-770 | 62332-0770-1562332-0770-30 |
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 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 200 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-114 |
| 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 | A-S Medication Solutions | 50090-2131 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-3914 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-719 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Proficient Rx LP | 63187-487 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Coupler LLC | 67046-0358 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Coupler LLC | 67046-0359 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Coupler LLC | 67046-0749 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7223 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7544 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1479 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1908 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1978 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2343 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2406 |
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