Prescription drug · ANDA
Topiramate NDC 69097-123
Topiramate 50 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-123-03 | 69097012303 | 60 TABLET in 1 BOTTLE (69097-123-03)Marketed from Jun 12, 2014 | |
| 69097-123-12 | 69097012312 | 500 TABLET in 1 BOTTLE (69097-123-12)Marketed from Jun 12, 2014 | |
| 69097-123-15 | 69097012315 | 1000 TABLET in 1 BOTTLE (69097-123-15)Marketed from Jun 12, 2014 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cipla USA 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 69097-123_71f493d9-3aaa-4b13-8057-012e96e11dbcSPL ID 71f493d9-3aaa-4b13-8057-012e96e11dbcSPL set ID ca4ec248-285d-4066-8f89-5ed0c538c4c9RxCUI 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
N469097012303followed by a unit qualifier and the quantityPackage 69097-0123-03. 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 are 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 Adjunctive Therapy E…
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 25 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-1971 |
| 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 |
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