Prescription drug · ANDA
Topiramate NDC 31722-548
Topiramate 50 mg/1 · Capsule, Extended release · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-548-30 | 31722054830 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-548-30)Marketed from Apr 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 — 50 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217443
- 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 31722-548_c4f0c0d0-430f-4c9d-96f0-8c90f6af31e8SPL ID c4f0c0d0-430f-4c9d-96f0-8c90f6af31e8SPL set ID dbc52b16-b93d-4d83-942b-485c502db1faRxCUI 1436239, 1437278, 1437283, 1437288UNII 0H73WJJ391UPC 0331722548304, 0331722547307, 0331722550307, 0331722549301
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
N431722054830followed by a unit qualifier and the quantityPackage 31722-0548-30. 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)
INDICATIONS AND USAGE Topiramate extended-release capsules 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 are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6…
Excerpt only. Read the full label for complete information.
About NDC 31722-548
- What is NDC 31722-548?
- 31722-548 is the product NDC for Topiramate, Topiramate 50 mg/1 capsule, extended release, listed with the FDA by Camber Pharmaceuticals, Inc.. 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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?
- 278 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 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 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0375 | 67046-0375-03 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-808 | 50268-0808-15 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-806 | 50268-0806-15 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-807 | 50268-0807-15 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-809 | 50268-0809-15 |
Other NDCs under ANDA 217443
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 | Camber Pharmaceuticals, Inc. | 31722-547 |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-549 |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-550 |