Prescription drug · ANDA
topiramate NDC 71205-202
Topiramate 25 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-202-30 | 71205020230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-202-30)Marketed from Jan 1, 2019 | |
| 71205-202-60 | 71205020260 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-202-60)Marketed from Jan 1, 2019 | |
| 71205-202-90 | 71205020290 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-202-90)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 — 25 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 090162
- 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 71205-202_ebe4977e-5a33-4587-8a06-f46c4d5b92bcSPL ID ebe4977e-5a33-4587-8a06-f46c4d5b92bcSPL set ID 2d6d236b-9808-4e18-b521-e7435d1fd5ccRxCUI 199888UNII 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
N471205020230followed by a unit qualifier and the quantityPackage 71205-0202-30. 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 are indicated for: • Epilepsy: initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1 ); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome ( 1.2 ) • Prophylaxis of migraine in patients 12 years of age and other ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. 1.2 Adjunctive Therapy Epile…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090162
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 50 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0214 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2481 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7067 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2480 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-117 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-115 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-116 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-118 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8817 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0488 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-752 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8828 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0495 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4515 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8835 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3660 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1064 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2102 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4760 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0288 |
Showing 20 of 34.