Prescription drug · ANDA
Topiramate NDC 72603-124
Topiramate 200 mg/1 · Capsule, Extended release · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-124-01 | 7260301240172603012401 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72603-124-01)Marketed from Jan 1, 2023 |
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
- Capsule, Extended release
- Route
- Oral
- Labeler
- NorthStar RxLLCNDC labeler code 72603
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210278
- 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 72603-124_f853ce07-7fb8-4c3a-96bc-9f4990f73351SPL ID f853ce07-7fb8-4c3a-96bc-9f4990f73351
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
N472603012401followed by a unit qualifier and the quantityPackage 72603-0124-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 72603-124
- What is NDC 72603-124?
- 72603-124 is the product NDC for Topiramate, Topiramate 200 mg/1 capsule, extended release, listed with the FDA by NorthStar RxLLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Topiramate.
- What is the active ingredient?
- Topiramate.
- Who is the labeler?
- NorthStar RxLLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Topiramate?
- 277 other product NDCs are listed under this name. See all Topiramate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Topiramate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-325 | 27808-0325-01 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-326 | 27808-0326-01 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-327 | 27808-0327-01 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-328 | 27808-0328-01 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-329 | 27808-0329-01 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-952 | 60760-0952-60 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0357 | 67046-0357-03 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1691 | 67046-1691-03 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-079 | 87441-0079-01 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Coupler LLC | 67046-1688 | 67046-1688-03 |
Other NDCs under ANDA 210278
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 25 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-120 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-123 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-121 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 72603-122 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-370 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-374 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-371 |
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-372 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Glenmark Pharmaceuticals Inc., USA | 68462-373 |