topiramate
- Product NDC
- 71335-2318
- 11-digit product format
- 713352318
- Labeler code
- 71335
- Product ID
- 71335-2318_6cafdf58-ef5b-4b0a-98c5-1c06fad0ef99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- Substance
- TOPIRAMATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0H73WJJ391 | TOPIRAMATE | 97240-79-4 | TOPIRAMATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2318-1 | 71335231801 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-1) | 2024-01-02 | No | No | Historical |
| 71335-2318-2 | 71335231802 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-2) | 2024-01-02 | No | No | Historical |
| 71335-2318-3 | 71335231803 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-3) | 2024-01-02 | No | No | Historical |
| 71335-2318-4 | 71335231804 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-4) | 2024-01-02 | No | No | Historical |
| 71335-2318-5 | 71335231805 | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-5) | 2024-01-02 | No | No | Historical |
| 71335-2318-6 | 71335231806 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-6) | 2024-01-02 | No | No | Historical |
| 71335-2318-7 | 71335231807 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-7) | 2024-01-02 | No | No | Historical |
| 71335-2318-8 | 71335231808 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-2318-8) | 2024-01-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| topiramate | Bryant Ranch Prepack | 2024-01-02 | HUMAN PRESCRIPTION DRUG LABEL | 100 |