TOPIRAMATE
- Product NDC
- 63187-077
- 11-digit product format
- 631870077
- Labeler code
- 63187
- Product ID
- 63187-077_f68b2272-7a9d-4838-89ff-a10064e49015
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090278
- 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 | 151226, 199888, 199889 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-077-30 | TOPIRAMATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 63187-077-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
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 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 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 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 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 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 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 |
|---|
| 63187-077 | TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 2 package rows | 20221012_a30c583a-4b0a-43a6-ae76-19b1a5e916ca.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 |
|---|
| 63187-077-30 | 63187007730 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-077-30) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 63187-077-60 | 63187007760 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-077-60) | 2019-01-01 | 0000-00-00 | No | No | Current |