Prescription drug · ANDA
Topiramate NDC 71335-0925
Topiramate 200 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0925-1 | 71335092501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0925-1)Marketed from Mar 1, 2019 | |
| 71335-0925-2 | 71335092502 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0925-2)Marketed from Aug 10, 2018 | |
| 71335-0925-3 | 71335092503 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0925-3)Marketed from Apr 4, 2024 | |
| 71335-0925-4 | 71335092504 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0925-4)Marketed from Apr 4, 2024 | |
| 71335-0925-5 | 71335092505 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-0925-5)Marketed from Apr 4, 2024 | |
| 71335-0925-6 | 71335092506 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-0925-6)Marketed from Apr 4, 2024 |
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 Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090278
- 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 71335-0925_01e04859-b5e0-4061-b270-c85cef0fe7e4SPL ID 01e04859-b5e0-4061-b270-c85cef0fe7e4SPL set ID 47ef2964-3a41-4bfd-86fb-d44560b9961fRxCUI 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
N471335092501followed by a unit qualifier and the quantityPackage 71335-0925-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 090278
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 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-004 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0325 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5165 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0487 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-710 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-707 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-711 |
| Topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-712 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-998 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0548 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-997 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-801 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-711 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-707 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-710 |
| Topiramate | Topiramate 200 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 62756-712 |
| Topiramate | Topiramate 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-060 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-214 |
| Topiramate | Topiramate 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-059 |
| Topiramate | Topiramate 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-077 |
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