Prescription drug · ANDA
Topiramate NDC 71610-492
Topiramate 100 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-492-30 | 71610049230 | 30 TABLET in 1 BOTTLE (71610-492-30)Marketed from Nov 17, 2020 | |
| 71610-492-45 | 71610049245 | 45 TABLET in 1 BOTTLE (71610-492-45)Marketed from Nov 17, 2020 | |
| 71610-492-53 | 71610049253 | 60 TABLET in 1 BOTTLE (71610-492-53)Marketed from Nov 17, 2020 | |
| 71610-492-60 | 71610049260 | 90 TABLET in 1 BOTTLE (71610-492-60)Marketed from Nov 17, 2020 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079162
- 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 71610-492_875c3303-147e-4bdf-98f2-8355c056e18fSPL ID 875c3303-147e-4bdf-98f2-8355c056e18fSPL set ID 3b18b43c-0de2-4acf-b0d5-f1b601d496deRxCUI 151226, 199888, 199889, 199890UNII 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
N471610049230followed by a unit qualifier and the quantityPackage 71610-0492-30. 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)
1. INDICATIONS AND USAGE Topiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial- onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ) Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adj…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079162
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 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-493 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Proficient Rx LP | 63187-228 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-278 |
| Topiramate | Topiramate 200 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-281 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-279 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-280 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | Cipla USA Inc. | 69097-816 |
| Topiramate | Topiramate 200 mg/1 | TabletOral | Cipla USA Inc. | 69097-819 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Cipla USA Inc. | 69097-817 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Cipla USA Inc. | 69097-818 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-485 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-486 |