Prescription drug · ANDA
topiramate NDC 71205-233
Topiramate 25 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-233-30 | 71205023330 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-233-30)Marketed from Jun 1, 2019 | |
| 71205-233-60 | 71205023360 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-233-60)Marketed from Jun 1, 2019 | |
| 71205-233-90 | 71205023390 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-233-90)Marketed from Jun 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 078235
- 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 71205-233_e394ff4b-4fb0-418c-866f-3e5d95461bfaSPL ID e394ff4b-4fb0-418c-866f-3e5d95461bfaSPL set ID 80481455-7ad7-4f44-8113-b8b61d8581a0RxCUI 199888UNII 0H73WJJ391UPC 0371205233600
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
N471205023330followed by a unit qualifier and the quantityPackage 71205-0233-30. 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 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 and topiramate capsules 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 A…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078235
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 | REMEDYREPACK INC. | 70518-1937 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5309 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1953 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2001 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2104 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0357 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-344 |
| Topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-345 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7351 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-137 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-135 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-136 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7460 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7468 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1180 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6928 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1116 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7568 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6929 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1143 |
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