Topiramate
- Product NDC
- 55700-217
- 11-digit product format
- 557000217
- Labeler code
- 55700
- Product ID
- 55700-217_5f7dfb59-773a-4d27-8c13-b812f489b135
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2015-02-20
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55700-217-30 | 2021-02-03 | C162847 | 48780-1 | ba0f9c33-48ed-a910-e053-dadaa90a0b85 | 40b11fee-1e7c-4ad8-bc44-6494ea4791a5 |
| 55700-217-60 | 2021-02-03 | C162847 | 48780-1 | ba0f9c33-48ed-a910-e053-dadaa90a0b85 | 40b11fee-1e7c-4ad8-bc44-6494ea4791a5 |
| 55700-217-90 | 2021-02-03 | C162847 | 48780-1 | ba0f9c33-48ed-a910-e053-dadaa90a0b85 | 40b11fee-1e7c-4ad8-bc44-6494ea4791a5 |
| 55700-217-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-48ed-a910-e053-dadaa90a0b85 | 40b11fee-1e7c-4ad8-bc44-6494ea4791a5 |
| 55700-217-60 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-48ed-a910-e053-dadaa90a0b85 | 40b11fee-1e7c-4ad8-bc44-6494ea4791a5 |
| 55700-217-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-48ed-a910-e053-dadaa90a0b85 | 40b11fee-1e7c-4ad8-bc44-6494ea4791a5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-217-30 | EA - Each | 55700-217 | 0cac187f-5748-4f5f-a167-d726ab937db5 | 1 | 2017-12-14 |
| 55700-217-60 | EA - Each | 55700-217 | 5c989668-bce7-4fd3-a070-6cd67d5c5c02 | 1 | 2017-12-14 |
| 55700-217-90 | EA - Each | 55700-217 | 958b7864-65a4-41c6-b0cc-fd25bebf598d | 1 | 2017-12-14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-217-30 | 55700021730 | 30 TABLET in 1 BOTTLE (55700-217-30) | 30 tablet | 2021-07-30 | 0000-00-00 | No | No | Current |
| 55700-217-60 | 55700021760 | 60 TABLET in 1 BOTTLE (55700-217-60) | 60 tablet | 2015-02-20 | 0000-00-00 | No | No | Current |