Prescription drug · ANDA
Topiramate NDC 62756-710
Topiramate 50 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-710-08 | 62756071008 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-710-08)Marketed from Mar 27, 2009 | |
| 62756-710-13 | 62756071013 | 500 TABLET, FILM COATED in 1 BOTTLE (62756-710-13)Marketed from Mar 27, 2009 | |
| 62756-710-18 | 62756071018 | 1000 TABLET, FILM COATED in 1 BOTTLE (62756-710-18)Marketed from Mar 27, 2009 | |
| 62756-710-83 | 62756071083 | 30 TABLET, FILM COATED in 1 BOTTLE (62756-710-83)Marketed from Mar 27, 2009 | |
| 62756-710-86 | 62756071086 | 60 TABLET, FILM COATED in 1 BOTTLE (62756-710-86)Marketed from Mar 27, 2009 | |
| 62756-710-88 | 62756071088 | 100 TABLET, FILM COATED in 1 BOTTLE (62756-710-88)Marketed from Mar 27, 2009 |
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
- 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 62756-710_b8c52970-05b0-43ea-9122-566998bf4524SPL ID b8c52970-05b0-43ea-9122-566998bf4524SPL set ID 2d9513e0-2fb8-46c9-bbd6-b03efd31c3efUNII 0H73WJJ391UPC 0362756711839, 0362756707832, 0362756712836
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
N462756071008followed by a unit qualifier and the quantityPackage 62756-0710-08. 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 is an antiepileptic (AED) agent indicated for: Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 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 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in pati…
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 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 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-059 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-077 |
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