TOPIRAMATE
- Product NDC
- 61919-172
- 11-digit product format
- 619190172
- Labeler code
- 61919
- Product ID
- 61919-172_9cad60e1-340f-1b7e-e053-2995a90a2a2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e5b1b0ba-27f8-4d5d-8943-8aed080fdedc | Product name | 4 | 20260306 |
| 6c26dd6d-01b5-4a80-b096-b3a6f7ca6077 | Product name | 2 | 20250623 |
| cb966f54-bbf0-40fb-b581-80c6648d510c | Product name | 4 | 20250623 |
| 6e2fb0d7-40d7-e97c-1375-fa022ff20193 | Product name | 4 | 20250305 |
| 3d272a3f-17c0-421d-bc43-3cbdb719258d | Product name | 1 | 20250303 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-172-60 | 2023-01-30 | C162847 | 48780-1 | f386c64a-14f7-0266-e053-dadaa90a7c1a | TOPIRAMATE |
| 61919-172-72 | 2023-01-30 | C162847 | 48780-1 | f386c64a-14f7-0266-e053-dadaa90a7c1a | TOPIRAMATE |
| 61919-172-90 | 2023-01-30 | C162847 | 48780-1 | f386c64a-14f7-0266-e053-dadaa90a7c1a | TOPIRAMATE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-172-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET | 60 | 6 | |
| 61919-172-72 | TOPIRAMATE | 72 in 1 BOTTLE | TABLET | 72 | 6 | |
| 61919-172-90 | TOPIRAMATE | 90 in 1 BOTTLE | TABLET | 90 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-172-60 | EA - Each | 61919-172 | 42aebbb2-1890-4a1b-8ade-5773a1cd41af | 1 | 2016-09-02 |
| 61919-172-72 | EA - Each | 61919-172 | 9de3dc9c-7acc-4d3e-b3ae-8965f35931f8 | 1 | 2016-09-02 |
| 61919-172-90 | EA - Each | 61919-172 | 31933657-42fa-4c57-b9e8-ab5fb4eb19f8 | 1 | 2016-09-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET [DIRECT RX] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET [DIRECT RX] | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 151226 | topiramate 50 MG Oral Tablet | PSN | 4ce9b4dd-bcff-4157-a859-aa816e2b1226 | 6 |
| 151226 | topiramate 50 MG Oral Tablet | SCD | 4ce9b4dd-bcff-4157-a859-aa816e2b1226 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-172-60 | 61919017260 | 60 TABLET in 1 BOTTLE (61919-172-60) | 60 tablet | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-172-72 | 61919017272 | 72 TABLET in 1 BOTTLE (61919-172-72) | 72 tablet | 2015-01-01 | 0000-00-00 | No | No | Current |
| 61919-172-90 | 61919017290 | 90 TABLET in 1 BOTTLE (61919-172-90) | 90 tablet | 2014-01-01 | 0000-00-00 | No | No | Current |