Prescription drug · ANDA
Topiramate NDC 69097-817
Topiramate 50 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-817-03 | 6909708170369097081703 | 60 TABLET in 1 BOTTLE (69097-817-03)Marketed from Jul 22, 2016 | |
| 69097-817-12 | 6909708171269097081712 | 500 TABLET in 1 BOTTLE (69097-817-12)Marketed from Jul 22, 2016 | |
| 69097-817-15 | 6909708171569097081715 | 1000 TABLET in 1 BOTTLE (69097-817-15)Marketed from Jul 22, 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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079162
- 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 69097-817_1b47473e-6644-4026-90e5-b169fce62b60SPL ID 1b47473e-6644-4026-90e5-b169fce62b60SPL set ID 4087eb3c-96e9-4d0a-b80b-663e1c86d256RxCUI 151226, 199888, 199889, 199890UNII 0H73WJJ391UPC 0369097817039, 0369097818036, 0369097816032, 0369097819033
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
N469097081703followed by a unit qualifier and the quantityPackage 69097-0817-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 69097-817
- What is NDC 69097-817?
- 69097-817 is the product NDC for Topiramate, Topiramate 50 mg/1 tablet, listed with the FDA by Cipla USA Inc.. 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?
- Cipla USA Inc., NDC labeler code 69097. 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 079162
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 50 mg/1 | TabletOral | Proficient Rx LP | 63187-228 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | Cipla USA Inc. | 69097-816 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Cipla USA Inc. | 69097-818 |
| Topiramate | Topiramate 200 mg/1 | TabletOral | Cipla USA Inc. | 69097-819 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-485 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-486 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-492 |
| Topiramate | Topiramate 200 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-493 |
| Topiramate | Topiramate 25 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-278 |
| Topiramate | Topiramate 50 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-279 |
| Topiramate | Topiramate 100 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-280 |
| Topiramate | Topiramate 200 mg/1 | TabletOral | EXELAN PHARMACEUTICALS INC. | 76282-281 |