Prescription drug · ANDA
Topiramate NDC 68071-1971
Topiramate 25 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-1971-3 | 68071197103 | 30 TABLET in 1 BOTTLE (68071-1971-3)Marketed from Feb 21, 2017 | |
| 68071-1971-6 | 68071197106 | 60 TABLET in 1 BOTTLE (68071-1971-6)Marketed from Feb 21, 2017 | |
| 68071-1971-9 | 68071197109 | 90 TABLET in 1 BOTTLE (68071-1971-9)Marketed from Feb 21, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076343
- 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 68071-1971_3ab5a044-1530-14af-e063-6394a90a35caSPL ID 3ab5a044-1530-14af-e063-6394a90a35caSPL set ID 490f109f-30cb-0790-e054-00144ff88e88RxCUI 199888UNII 0H73WJJ391UPC 0368071197198
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
N468071197103followed by a unit qualifier and the quantityPackage 68071-1971-03. 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 USP is an antiepileptic (AED) agent indicated for: Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1 ) Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) ( 1.2 ) 1.1 Monotherapy Epilepsy Topiramate tablets USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiven…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076343
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 | Coupler LLC | 67046-1688 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-729 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-734 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-735 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0195 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0208 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0337 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-279 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-276 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-278 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0625 |
| Topiramate | Topiramate 200 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-280 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3088 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Proficient Rx LP | 63187-696 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-4614 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-606 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | C | 61919-213 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-3389 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Proficient Rx LP | 63187-758 |
| Topiramate | Topiramate 200 mg/1 | TabletOral | Proficient Rx LP | 63187-963 |
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