Prescription drug · ANDA
Topiramate NDC 65862-174
Topiramate 200 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-174-05 | 65862017405 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-174-05)Marketed from Apr 11, 2022 | |
| 65862-174-60 | 65862017460 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-174-60)Marketed from Mar 27, 2009 | |
| 65862-174-99 | 65862017499 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-174-99)Marketed from Apr 11, 2022 |
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
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078462
- 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 65862-174_67afee59-3d84-418f-832c-d00abd43fe5bSPL ID 67afee59-3d84-418f-832c-d00abd43fe5bSPL set ID 32b48ea0-a215-43b8-83b4-a5435a686d68RxCUI 151226, 199888, 199889, 199890UNII 0H73WJJ391UPC 0365862171603, 0365862172600
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
N465862017405followed by a unit qualifier and the quantityPackage 65862-0174-05. 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 078462
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 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-173 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-171 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-172 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8594 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8595 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-443 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-471 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8593 |