Prescription drug · ANDA
Lamotrigine NDC 71335-1919
Lamotrigine 200 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1919-1 | 71335191901 | 30 TABLET in 1 BOTTLE (71335-1919-1)Marketed from Jul 22, 2021 | |
| 71335-1919-2 | 71335191902 | 60 TABLET in 1 BOTTLE (71335-1919-2)Marketed from Jul 26, 2024 | |
| 71335-1919-3 | 71335191903 | 90 TABLET in 1 BOTTLE (71335-1919-3)Marketed from Oct 15, 2024 | |
| 71335-1919-4 | 71335191904 | 45 TABLET in 1 BOTTLE (71335-1919-4)Marketed from Jun 16, 2025 | |
| 71335-1919-5 | 71335191905 | 180 TABLET in 1 BOTTLE (71335-1919-5)Marketed from Jun 16, 2025 | |
| 71335-1919-6 | 71335191906 | 14 TABLET in 1 BOTTLE (71335-1919-6)Marketed from Jun 16, 2025 |
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)
- lamotrigine
- Active ingredients
- Lamotrigine — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077633
- 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 71335-1919_cf03f130-067f-401c-8501-0d78a989a319SPL ID cf03f130-067f-401c-8501-0d78a989a319SPL set ID cf03f130-067f-401c-8501-0d78a989a319RxCUI 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
N471335191901followed by a unit qualifier and the quantityPackage 71335-1919-01. 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 is indicated for: Epilepsy — adjunctive therapy in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) 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 Treatm…
Excerpt only. Read the full label for complete information.
About NDC 71335-1919
- What is NDC 71335-1919?
- 71335-1919 is the product NDC for Lamotrigine, Lamotrigine 200 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 6 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 100 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-772 | 46708-0772-1046708-0772-30 |
| 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 200 mg/1 | Tablet, Orally disintegratingOral | Alembic Pharmaceuticals Limited | 46708-773 | 46708-0773-1046708-0773-30 |
Other NDCs under ANDA 077633
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 | Cardinal Health 107, LLC | 55154-2331 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2330 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7008 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | American Health Packaging | 60687-704 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2065 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8267 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3514 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7964 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7975 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7871 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-005 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2328 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8150 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | A-S Medication Solutions | 50090-5850 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-131 |
| Lamotrigine | Lamotrigine 200 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-134 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-685 |
| Lamotrigine | Lamotrigine 100 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-132 |
| Lamotrigine | Lamotrigine 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 65841-682 |
| Lamotrigine | Lamotrigine 150 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-133 |
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