Topiramate
- Product NDC
- 70934-022
- 11-digit product format
- 709340022
- Labeler code
- 70934
- Product ID
- 70934-022_b7b074c4-63fc-3285-e053-2995a90a3223
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2018-05-11
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70934-022-30 | Topiramate | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
| 70934-022-60 | Topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70934-022 | TOPIRAMATE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS] | 3 | Legacy NDC, 2 package rows | 20201231_77f62dd7-0b58-03a9-e053-2a91aa0a69f5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70934-022-30 | 70934002230 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-022-30) | 2018-05-11 | 0000-00-00 | No | No | Current |
| 70934-022-60 | 70934002260 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-022-60) | 2019-07-30 | 0000-00-00 | No | No | Current |