Topiramate
- Product NDC
- 45865-551
- 11-digit product format
- 458650551
- Labeler code
- 45865
- Product ID
- 45865-551_7d62746b-f8db-32de-e053-2a91aa0add64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- medsource pharmaceuticals
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- 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
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 |
|---|
| 45865-551-90 | Topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-551 | TOPIRAMATE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20181220_7d62746b-f8da-32de-e053-2a91aa0add64.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 |
|---|
| 45865-551-90 | 45865055190 | 90 TABLET, FILM COATED in 1 BOTTLE (45865-551-90) | 2018-06-01 | 0000-00-00 | No | No | Current |