Topiramate
- Product NDC
- 16571-705
- 11-digit product format
- 165710705
- Labeler code
- 16571
- Product ID
- 16571-705_2bcd3451-b2f7-4ec0-9113-f2a4cdf275e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA078462
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-705 | TOPIRAMATE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 8 | Legacy NDC | 20240430_296c5387-1bf4-4137-87f2-2ebab4933e2c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16571-705-06 | 16571070506 | 60 TABLET, FILM COATED in 1 BOTTLE (16571-705-06) | 2009-03-27 | 0000-00-00 | No | No | Current |
| 16571-705-10 | 16571070510 | 1000 TABLET, FILM COATED in 1 BOTTLE (16571-705-10) | 2022-04-11 | 0000-00-00 | No | No | Current |