Topiramate
- Product NDC
- 70518-3067
- 11-digit product format
- 705183067
- Labeler code
- 70518
- Product ID
- 70518-3067_c3dfd903-81c4-2208-e053-2995a90a2bb5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077627
- Marketing category
- ANDA
- Marketing start
- 2021-04-07
- 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3067 | TOPIRAMATE TABLET, FILM COATED [REMEDYREPACK INC.] | 5 | Legacy NDC | 20240312_86b0ef4e-aaf4-4f37-b576-bc11c3e0bf08.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3067-0 | 70518306700 | 30 POUCH in 1 BOX (70518-3067-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3067-1) | 30 pouch | 2021-04-07 | 0000-00-00 | No | No | Current |
| 70518-3067-2 | 70518306702 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3067-2) | | 2021-06-03 | 0000-00-00 | No | No | Current |