Topiramate
- Product NDC
- 70518-0517
- 11-digit product format
- 705180517
- Labeler code
- 70518
- Product ID
- 70518-0517_85931a38-2c0d-7249-e053-2a91aa0a103b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2017-05-10
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 25 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record