Prescription drug · ANDA
Topiramate NDC 43598-941
Topiramate 100 mg/1 · Capsule, Extended release · Oral · Dr. Reddys Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-941-01 | 43598094101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-941-01)Marketed from Feb 1, 2026 | |
| 43598-941-30 | 43598094130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-941-30)Marketed from Feb 1, 2026 |
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 — 100 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Dr. Reddys Laboratories Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217231
- 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 43598-941_641acdcc-9618-84e0-a09a-cbf956ffbe61SPL ID 641acdcc-9618-84e0-a09a-cbf956ffbe61SPL set ID f07d81bc-5090-fbc5-2945-557cf002849cRxCUI 1436239, 1437278, 1437283, 1437288UNII 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
N443598094101followed by a unit qualifier and the quantityPackage 43598-0941-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.