Prescription drug · ANDA
Topiramate NDC 76282-278
Topiramate 25 mg/1 · Tablet · Oral · EXELAN PHARMACEUTICALS INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-278-10 | 76282027810 | 1000 TABLET in 1 BOTTLE (76282-278-10)Marketed from Sep 7, 2020 | |
| 76282-278-60 | 76282027860 | 60 TABLET in 1 BOTTLE (76282-278-60)Marketed from Sep 7, 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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- EXELAN PHARMACEUTICALS INC.
- 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 76282-278_9c981813-533d-40b5-b9ea-5648dd7c7da0SPL ID 9c981813-533d-40b5-b9ea-5648dd7c7da0SPL set ID 690baf58-1ec9-463e-99b7-d601362ea56bRxCUI 151226, 199888, 199889, 199890UNII 0H73WJJ391UPC 0376282279107, 0376282280103, 0376282278100, 0376282281100
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
N476282027810followed by a unit qualifier and the quantityPackage 76282-0278-10. 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 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-492 |
| 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 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 |