Prescription drug · ANDA
Topiramate NDC 63187-773
Topiramate 25 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-773-30 | 63187077330 | 30 TABLET in 1 BOTTLE (63187-773-30)Marketed from Nov 1, 2016 | |
| 63187-773-60 | 63187077360 | 60 TABLET in 1 BOTTLE (63187-773-60)Marketed from Nov 1, 2016 | |
| 63187-773-90 | 63187077390 | 90 TABLET in 1 BOTTLE (63187-773-90)Marketed from Nov 1, 2016 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076343
- 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 63187-773_a3b868e4-d9b8-4e48-a11e-8bf67f9f4b52SPL ID a3b868e4-d9b8-4e48-a11e-8bf67f9f4b52SPL set ID 2917ba32-3355-4d64-966a-8518e6fafdbeRxCUI 199888UNII 0H73WJJ391UPC 0363187773304
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
N463187077330followed by a unit qualifier and the quantityPackage 63187-0773-30. 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)
Topiramate tablets USP is an antiepileptic (AED) agent indicated for: • Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1 ) • Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) ( 1.2 ) 1.1 Monotherapy Epilepsy Topiramate tablets USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effect…
Excerpt only. Read the full label for complete information.
About NDC 63187-773
- What is NDC 63187-773?
- 63187-773 is the product NDC for Topiramate, Topiramate 25 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 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?
- Proficient Rx LP, NDC labeler code 63187. 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?
- 276 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 076343
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 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-729 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-734 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-735 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-3389 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-3461 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-4614 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6827 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6828 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-6895 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-606 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | C | 61919-213 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Proficient Rx LP | 63187-696 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Proficient Rx LP | 63187-758 |
| Topiramate | Topiramate 200 mg/1 | TabletOral | Proficient Rx LP | 63187-963 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Coupler LLC | 67046-1688 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-1971 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3088 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | Cipla USA Inc. | 69097-122 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Cipla USA Inc. | 69097-123 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Cipla USA Inc. | 69097-124 |
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