Prescription drug · ANDA
Topiramate NDC 63187-059
Topiramate 50 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-059-30 | 63187005930 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-059-30)Marketed from Jan 1, 2019 | |
| 63187-059-90 | 63187005990 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-059-90)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 090278
- 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 63187-059_f68b2272-7a9d-4838-89ff-a10064e49015SPL ID f68b2272-7a9d-4838-89ff-a10064e49015SPL set ID a30c583a-4b0a-43a6-ae76-19b1a5e916caRxCUI 151226, 199888, 199889UNII 0H73WJJ391UPC 0363187077303, 0363187060305
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
N463187005930followed by a unit qualifier and the quantityPackage 63187-0059-30. 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)
INDICATIONS AND USAGE Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. Adjunctive Therapy Epilepsy Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary g…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090278
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 | PD-Rx Pharmaceuticals, Inc. | 72789-004 |
| Topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0925 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0325 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5165 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0487 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-710 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-707 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-711 |
| Topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-712 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-998 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0548 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-997 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-801 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-711 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-707 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-710 |
| Topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-712 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-060 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-214 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-077 |
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