Prescription drug · ANDA
Topiramate NDC 72888-228
Topiramate 15 mg/1 · Capsule · Oral · Advagen Pharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-228-05 | 7288802280572888022805 | 500 CAPSULE in 1 BOTTLE (72888-228-05)Marketed from May 27, 2025 | |
| 72888-228-12 | 7288802281272888022812 | 120 CAPSULE in 1 BOTTLE (72888-228-12)Marketed from May 27, 2025 | |
| 72888-228-30 | 7288802283072888022830 | 30 CAPSULE in 1 BOTTLE (72888-228-30)Marketed from May 27, 2025 | |
| 72888-228-60 | 7288802286072888022860 | 60 CAPSULE in 1 BOTTLE (72888-228-60)Marketed from May 27, 2025 | |
| 72888-228-67 | 7288802286772888022867 | 240 CAPSULE in 1 BOTTLE (72888-228-67)Marketed from May 27, 2025 |
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 — 15 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Advagen Pharma LtdNDC labeler code 72888
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216683
- 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 72888-228_4e8dd02d-2263-78d0-e063-6294a90a5f0bSPL ID 4e8dd02d-2263-78d0-e063-6294a90a5f0bSPL set ID 48169bbc-4fb2-4bc4-9bdd-de71bf7722dfRxCUI 205315, 205316, 252413UNII 0H73WJJ391UPC 0372888228051, 0372888230672, 0372888228679, 0372888229126, 0372888229676, 0372888230054, 0372888228129, 0372888228303, 0372888229607, 0372888230122, 0372888228600, 0372888229058, 0372888230603, 0372888230306
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
N472888022805followed by a unit qualifier and the quantityPackage 72888-0228-05. 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 capsules is 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 capsules 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…
Excerpt only. Read the full label for complete information.
About NDC 72888-228
- What is NDC 72888-228?
- 72888-228 is the product NDC for Topiramate, Topiramate 15 mg/1 capsule, listed with the FDA by Advagen Pharma Ltd. It has 5 package NDCs, 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?
- Advagen Pharma Ltd, NDC labeler code 72888. 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 216683
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 | CapsuleOral | Advagen Pharma Ltd | 72888-229 |
| Topiramate | Topiramate 50 mg/1 | CapsuleOral | Advagen Pharma Ltd | 72888-230 |