Prescription drug · ANDA
Topiramate NDC 68084-345
Topiramate 200 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-345-21 | 68084034521 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-345-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-345-11)Marketed from Apr 13, 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 — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health Packaging
- 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 68084-345_40052c1b-5558-373b-e063-6394a90ad7d4SPL ID 40052c1b-5558-373b-e063-6394a90ad7d4SPL set ID 1af94c80-2b17-409a-98f6-ce00f942351dRxCUI 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
N468084034521followed by a unit qualifier and the quantityPackage 68084-0345-21. 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 Adjunctive…
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 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 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1147 |
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