Topiramate
- Product NDC
- 68387-558
- 11-digit product format
- 683870558
- Labeler code
- 68387
- Product ID
- 68387-558_f66fe0dd-f036-43c8-8527-c1384dbd6791
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Keltman Pharmaceuticals Inc.
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2010-07-30
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 68387-558-90 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d607-8e05-e053-dbdaa90a074a | Topiramate |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68387-558-90 | Topiramate | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68387-558-90 | EA - Each | 68387-558 | 1850e7fd-6d0d-4fb4-a89c-738bc46fa88f | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| Topiramate | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199889 | topiramate 100 MG Oral Tablet | PSN | 47fd4c44-56fa-4864-af5d-7b65c7b746d7 | 1 |
| 199890 | topiramate 200 MG Oral Tablet | PSN | 47fd4c44-56fa-4864-af5d-7b65c7b746d7 | 1 |
| 199888 | topiramate 25 MG Oral Tablet | PSN | 47fd4c44-56fa-4864-af5d-7b65c7b746d7 | 1 |
| 199889 | topiramate 100 MG Oral Tablet | SCD | 47fd4c44-56fa-4864-af5d-7b65c7b746d7 | 1 |
| 199890 | topiramate 200 MG Oral Tablet | SCD | 47fd4c44-56fa-4864-af5d-7b65c7b746d7 | 1 |
| 199888 | topiramate 25 MG Oral Tablet | SCD | 47fd4c44-56fa-4864-af5d-7b65c7b746d7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68387-558-90 | 68387055890 | 90 in 1 BOTTLE, PLASTIC | Historical |