Topiramate
- Product NDC
- 55700-596
- 11-digit product format
- 557000596
- Labeler code
- 55700
- Product ID
- 55700-596_0f71fae0-6f40-44ea-b272-1e060f410f37
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55700-596-27 | 2025-01-09 | C162847 | 48780-1 | 1030e365-44ce-111a-e063-dadaa90a10e2 | eabd9b52-0d8a-4f6d-ba1f-32c2e6e1d057 |
| 55700-596-30 | 2025-01-09 | C162847 | 48780-1 | 1030e365-44ce-111a-e063-dadaa90a10e2 | eabd9b52-0d8a-4f6d-ba1f-32c2e6e1d057 |
| 55700-596-60 | 2025-01-09 | C162847 | 48780-1 | 1030e365-44ce-111a-e063-dadaa90a10e2 | eabd9b52-0d8a-4f6d-ba1f-32c2e6e1d057 |
| 55700-596-90 | 2025-01-09 | C162847 | 48780-1 | 1030e365-44ce-111a-e063-dadaa90a10e2 | eabd9b52-0d8a-4f6d-ba1f-32c2e6e1d057 |
| 55700-596-27 | 2024-01-30 | C162847 | 48780-1 | 1030e365-44ce-111a-e063-dadaa90a10e2 | eabd9b52-0d8a-4f6d-ba1f-32c2e6e1d057 |
| 55700-596-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-44ce-111a-e063-dadaa90a10e2 | eabd9b52-0d8a-4f6d-ba1f-32c2e6e1d057 |
| 55700-596-60 | 2024-01-30 | C162847 | 48780-1 | 1030e365-44ce-111a-e063-dadaa90a10e2 | eabd9b52-0d8a-4f6d-ba1f-32c2e6e1d057 |
| 55700-596-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-44ce-111a-e063-dadaa90a10e2 | eabd9b52-0d8a-4f6d-ba1f-32c2e6e1d057 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-596-27 | EA - Each | 55700-596 | 66d3d1eb-ac2e-4af2-ae61-a2c2eb3e1038 | 1 | 2018-05-09 |
| 55700-596-30 | EA - Each | 55700-596 | b33643f6-1c66-4760-a6ab-720c6c3b46c4 | 1 | 2018-05-09 |
| 55700-596-60 | EA - Each | 55700-596 | 05e2ae8c-1893-4c3e-b250-1133cf884f39 | 1 | 2018-05-09 |
| 55700-596-90 | EA - Each | 55700-596 | 71acc941-5c9d-4747-a50d-99effb89c96d | 1 | 2018-05-09 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-596-27 | 55700059627 | 270 TABLET, FILM COATED in 1 BOTTLE (55700-596-27) | 2018-04-07 | 0000-00-00 | No | No | Current |
| 55700-596-30 | 55700059630 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-596-30) | 2018-04-07 | 0000-00-00 | No | No | Current |
| 55700-596-60 | 55700059660 | 60 TABLET, FILM COATED in 1 BOTTLE (55700-596-60) | 2018-04-07 | 0000-00-00 | No | No | Current |
| 55700-596-90 | 55700059690 | 90 TABLET, FILM COATED in 1 BOTTLE (55700-596-90) | 2018-04-07 | 0000-00-00 | No | No | Current |