Prescription drug · ANDA
topiramate NDC 68788-7351
Topiramate 50 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68788-7351Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7351Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7351-1 | 6878873510168788735101 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-7351-1)Marketed from Feb 27, 2019 | |
| 68788-7351-3 | 6878873510368788735103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-7351-3)Marketed from Feb 27, 2019 | |
| 68788-7351-5 | 6878873510568788735105 | 15 TABLET, FILM COATED in 1 BOTTLE (68788-7351-5)Marketed from Feb 27, 2019 | |
| 68788-7351-6 | 6878873510668788735106 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7351-6)Marketed from Feb 27, 2019 | |
| 68788-7351-9 | 6878873510968788735109 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-7351-9)Marketed from Feb 27, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078235
- 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 68788-7351_121d32bf-69da-4714-aff6-1ac13caafe54SPL ID 121d32bf-69da-4714-aff6-1ac13caafe54
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
N468788735101followed by a unit qualifier and the quantityPackage 68788-7351-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68788-7351
- What is NDC 68788-7351?
- 68788-7351 is the product NDC for topiramate, Topiramate 50 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?
- 286 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 | Ascend Laboratories, LLC | 67877-793 | 67877-0793-0167877-0793-0567877-0793-30+1 more |
| Topiramate | Topiramate 50 mg/1 | Capsule, Extended releaseOral | Ascend Laboratories, LLC | 67877-794 | 67877-0794-0167877-0794-0567877-0794-30+1 more |
| Topiramate | Topiramate 100 mg/1 | Capsule, Extended releaseOral | Ascend Laboratories, LLC | 67877-795 | 67877-0795-0167877-0795-0567877-0795-30+1 more |
| Topiramate | Topiramate 200 mg/1 | Capsule, Extended releaseOral | Ascend Laboratories, LLC | 67877-796 | 67877-0796-0167877-0796-0567877-0796-06+1 more |
| Topiramate | Topiramate 25 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-325 | 27808-0325-01 |
| Topiramate | Topiramate 150 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-328 | 27808-0328-01 |
| 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 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 |
Other NDCs under ANDA 078235
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 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1684 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1953 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-429 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-649 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-577 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-647 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0233 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-648 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7146 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-650 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7142 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1937 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-233 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6929 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2104 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0357 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0375 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-343 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-342 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-344 |
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