Prescription drug · ANDA
Topiramate NDC 70748-277
Topiramate 100 mg/1 · Capsule, Extended release · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70748-277-06 | 70748027706 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-277-06)Marketed from Feb 3, 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
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215561
- 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 70748-277_68180c67-ab30-49d0-aece-5a8d476097e2SPL ID 68180c67-ab30-49d0-aece-5a8d476097e2SPL set ID e310afcd-1260-434e-a994-34549c789d99RxCUI 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
N470748027706followed by a unit qualifier and the quantityPackage 70748-0277-06. 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 extended-release capsules USP are indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 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 extended-release capsules USP are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215561
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 | Lupin Pharmaceuticals, Inc. | 70748-275 |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 70748-276 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 70748-278 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.