TOPIRAMATE
- Product NDC
- 43602-460
- 11-digit product format
- 436020460
- Labeler code
- 43602
- Product ID
- 43602-460_aae1df09-1482-4aef-a038-11295c610473
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals, Inc.
- Application
- ANDA215414
- Marketing category
- ANDA
- Marketing start
- 2021-08-26
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43602-460 | TOPIRAMATE TABLET [ASCENT PHARMACEUTICALS, INC.] | 4 | Legacy NDC | 20210908_41a5a961-8756-464c-aef3-22f2c9047609.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43602-460-10 | 43602046010 | 1000 TABLET in 1 BOTTLE (43602-460-10) | 1000 tablet | 2021-08-26 | 0000-00-00 | No | No | Current |
| 43602-460-30 | 43602046030 | 30 TABLET in 1 BOTTLE (43602-460-30) | 30 tablet | 2021-08-26 | 0000-00-00 | No | No | Current |