Prescription drug · ANDA
topiramate NDC 71335-1116
Topiramate 200 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1116-1 | 7133511160171335111601 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1116-1)Marketed from Oct 22, 2020 | |
| 71335-1116-2 | 7133511160271335111602 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1116-2)Marketed from Feb 22, 2019 | |
| 71335-1116-3 | 7133511160371335111603 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1116-3)Marketed from Jul 8, 2022 | |
| 71335-1116-4 | 7133511160471335111604 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1116-4)Marketed from Jul 8, 2022 | |
| 71335-1116-5 | 7133511160571335111605 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1116-5)Marketed from Jul 8, 2022 | |
| 71335-1116-6 | 7133511160671335111606 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1116-6)Marketed from Jul 8, 2022 |
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 — 200 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-1116_0884b0e8-d3f8-400b-b3a3-f881a4e56aefSPL ID 0884b0e8-d3f8-400b-b3a3-f881a4e56aefSPL set ID 8abe45eb-cc75-4625-ae3d-5b2a038c4907RxCUI 199890UNII 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
N471335111601followed by a unit qualifier and the quantityPackage 71335-1116-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Topiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 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 tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjun…
Excerpt only. Read the full label for complete information.
About NDC 71335-1116
- What is NDC 71335-1116?
- 71335-1116 is the product NDC for topiramate, Topiramate 200 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 6 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 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 | Major Pharmaceuticals | 0904-6928 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6929 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3926 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5309 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5853 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-806 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-807 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-808 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-809 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-429 |
| topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-746 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-848 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7142 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7146 |
| topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-075 |
| 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 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-648 |
| topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-649 |
| topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-650 |
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