Topiramate
- Product NDC
- 55700-228
- 11-digit product format
- 557000228
- Labeler code
- 55700
- Product ID
- 55700-228_34f73ab7-bf1e-48d1-921b-7cc4022901b4
- 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
- 2014-06-12
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 50 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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55700-228-18 | 2025-01-08 | C162847 | 48780-1 | f386c64a-280d-0266-e053-dadaa90a7c1a | 2ef6d929-8ca8-4d37-a213-9cd92f219795 |
| 55700-228-30 | 2025-01-08 | C162847 | 48780-1 | f386c64a-280d-0266-e053-dadaa90a7c1a | 2ef6d929-8ca8-4d37-a213-9cd92f219795 |
| 55700-228-60 | 2025-01-08 | C162847 | 48780-1 | f386c64a-280d-0266-e053-dadaa90a7c1a | 2ef6d929-8ca8-4d37-a213-9cd92f219795 |
| 55700-228-90 | 2025-01-08 | C162847 | 48780-1 | f386c64a-280d-0266-e053-dadaa90a7c1a | 2ef6d929-8ca8-4d37-a213-9cd92f219795 |
| 55700-228-18 | 2023-01-30 | C162847 | 48780-1 | f386c64a-280d-0266-e053-dadaa90a7c1a | 2ef6d929-8ca8-4d37-a213-9cd92f219795 |
| 55700-228-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-280d-0266-e053-dadaa90a7c1a | 2ef6d929-8ca8-4d37-a213-9cd92f219795 |
| 55700-228-60 | 2023-01-30 | C162847 | 48780-1 | f386c64a-280d-0266-e053-dadaa90a7c1a | 2ef6d929-8ca8-4d37-a213-9cd92f219795 |
| 55700-228-90 | 2023-01-30 | C162847 | 48780-1 | f386c64a-280d-0266-e053-dadaa90a7c1a | 2ef6d929-8ca8-4d37-a213-9cd92f219795 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-228-18 | EA - Each | 55700-228 | 40e5c213-ee9b-4bd5-b398-43ffb4466ec8 | 1 | 2019-08-06 |
| 55700-228-30 | EA - Each | 55700-228 | 1fdd88a8-3b9d-4e4b-91f5-ef3d4280ab9b | 1 | 2017-04-05 |
| 55700-228-60 | EA - Each | 55700-228 | be32a726-e124-41b3-9b20-4ea61547a05f | 1 | 2017-04-05 |
| 55700-228-90 | EA - Each | 55700-228 | 7835a1c9-3e00-4a58-9506-5a66a342fad0 | 1 | 2017-04-05 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55700-228-18 | 55700022818 | 180 TABLET in 1 BOTTLE (55700-228-18) | 180 tablet | 2020-10-13 | 0000-00-00 | No | No | Current |
| 55700-228-30 | 55700022830 | 30 TABLET in 1 BOTTLE (55700-228-30) | 30 tablet | 2014-06-12 | 0000-00-00 | No | No | Current |
| 55700-228-60 | 55700022860 | 60 TABLET in 1 BOTTLE (55700-228-60) | 60 tablet | 2014-06-12 | 0000-00-00 | No | No | Current |
| 55700-228-90 | 55700022890 | 90 TABLET in 1 BOTTLE (55700-228-90) | 90 tablet | 2014-06-12 | 0000-00-00 | No | No | Current |