Topiramate
- Product NDC
- 63187-118
- 11-digit product format
- 631870118
- Labeler code
- 63187
- Product ID
- 63187-118_383715b0-118d-4561-a46a-dd23bb680352
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077627
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Substance
- TOPIRAMATE
- Active strength
- 25 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topiramate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 199888 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-118-30 | Topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 63187-118-60 | Topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 63187-118-90 | Topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-118 | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 3 package rows | 20210121_a712d050-d5de-4685-a80a-548ab080fdb7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-118-30 | 63187011830 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-118-30) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-118-60 | 63187011860 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-118-60) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-118-90 | 63187011890 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-118-90) | 2019-01-01 | 0000-00-00 | No | No | Current |