topiramate
- Product NDC
- 71335-9727
- 11-digit product format
- 713359727
- Labeler code
- 71335
- Product ID
- 71335-9727_e00d0107-e233-4b4c-a837-9a2d0123c8b4
- 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
- 25 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 |
|---|
| 71335-9727-0 | 71335972700 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-0) | 2024-04-05 | No | No | Historical |
| 71335-9727-1 | 71335972701 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-1) | 2023-05-30 | No | No | Historical |
| 71335-9727-2 | 71335972702 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-2) | 2024-04-05 | No | No | Historical |
| 71335-9727-3 | 71335972703 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-3) | 2023-06-30 | No | No | Historical |
| 71335-9727-4 | 71335972704 | 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-4) | 2024-02-20 | No | No | Historical |
| 71335-9727-5 | 71335972705 | 84 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-5) | 2024-04-05 | No | No | Historical |
| 71335-9727-6 | 71335972706 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-6) | 2023-08-02 | No | No | Historical |
| 71335-9727-7 | 71335972707 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-7) | 2024-04-05 | No | No | Historical |
| 71335-9727-8 | 71335972708 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-8) | 2024-04-05 | No | No | Historical |
| 71335-9727-9 | 71335972709 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9727-9) | 2024-04-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| topiramate | Bryant Ranch Prepack | 2024-08-08 | HUMAN PRESCRIPTION DRUG LABEL | 103 |