Prescription drug · ANDA
Topiramate NDC 63187-479
Topiramate 50 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-479-30 | 63187047930 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-479-30)Marketed from Jan 1, 2019 | |
| 63187-479-60 | 63187047960 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-479-60)Marketed from Jan 1, 2019 | |
| 63187-479-90 | 63187047990 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-479-90)Marketed from Jan 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)
- Topiramate
- Generic name (nonproprietary)
- topiramate
- Active ingredients
- Topiramate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077627
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
- Identifiers
- Product ID 63187-479_827436d3-2e3e-4a88-ab20-190eba38810aSPL ID 827436d3-2e3e-4a88-ab20-190eba38810aSPL set ID 5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8RxCUI 151226, 199889UNII 0H73WJJ391
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
N463187047930followed by a unit qualifier and the quantityPackage 63187-0479-30. 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 .
Indications (excerpt from the label)
Topiramate tablets USP are an antiepileptic (AED) agent indicated for: • Monotherapy epilepsy: Initial monotherapy in patients ≥10 years of age with partial onset or primary generalized tonic-clonic seizures (1.1) • Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2) 1.1 Monotherapy Epilepsy Topiramate tablets USP are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiv…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077627
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 |
|---|---|---|---|---|
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-109 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-108 |
| Topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-110 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-153 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-608 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-079 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4340 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-283 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-118 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2955 |