Prescription drug · ANDA
topiramate NDC 65841-652
Topiramate 25 mg/1 · Capsule, Coated pellets · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-652-01 | 65841065201 | 100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-01)Marketed from Oct 14, 2009 | |
| 65841-652-05 | 65841065205 | 500 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-05)Marketed from Oct 14, 2009 | |
| 65841-652-10 | 65841065210 | 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-10)Marketed from Oct 14, 2009 | |
| 65841-652-14 | 65841065214 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-14)Marketed from Oct 14, 2009 | |
| 65841-652-16 | 65841065216 | 90 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-16)Marketed from Oct 14, 2009 | |
| 65841-652-17 | 65841065217 | 28 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-652-17)Marketed from Oct 14, 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 — 25 mg/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078877
- 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 65841-652_c45924d5-c45b-4f31-afa5-0cbc090d2816SPL ID c45924d5-c45b-4f31-afa5-0cbc090d2816SPL set ID 6f9d59e3-d10d-48f3-af01-83ba3e1e3a2bRxCUI 205315, 205316, 252413UNII 0H73WJJ391UPC 0368382005144, 0368382004147
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
N465841065201followed by a unit qualifier and the quantityPackage 65841-0652-01. 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 .
Other NDCs under ANDA 078877
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 15 mg/1 | Capsule, Coated pelletsOral | Zydus Lifesciences Limited | 65841-651 |
| topiramate | Topiramate 50 mg/1 | Capsule, Coated pelletsOral | Zydus Pharmaceuticals USA Inc. | 68382-498 |
| topiramate | Topiramate 25 mg/1 | Capsule, Coated pelletsOral | REMEDYREPACK INC. | 70518-4247 |
| topiramate | Topiramate 50 mg/1 | Capsule, Coated pelletsOral | Zydus Lifesciences Limited | 65841-846 |
| topiramate | Topiramate 25 mg/1 | Capsule, Coated pelletsOral | Zydus Pharmaceuticals USA Inc. | 68382-005 |
| topiramate | Topiramate 15 mg/1 | Capsule, Coated pelletsOral | Zydus Pharmaceuticals USA Inc. | 68382-004 |