Topiramate
- Product NDC
- 47335-712
- 11-digit product format
- 473350712
- Labeler code
- 47335
- Product ID
- 47335-712_d4bed9ab-a090-49fe-a95e-5a7ce29c78ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- Substance
- TOPIRAMATE
- Active strength
- 200 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topiramate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 151226, 199888, 199889, 199890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-712-08 | Topiramate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 22 |
| 47335-712-13 | Topiramate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 22 |
| 47335-712-18 | Topiramate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 22 |
| 47335-712-83 | Topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 22 |
| 47335-712-86 | Topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 22 |
| 47335-712-88 | Topiramate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-712 | TOPIRAMATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 20 | Current NDC, Legacy NDC, 6 package rows | 20231229_3c909a53-ae66-4b28-a741-b60bb25a69cf.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 |
|---|
| 47335-712-08 | 47335071208 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-712-08) | 2014-12-15 | 0000-00-00 | No | No | Current |
| 47335-712-13 | 47335071213 | 500 TABLET, FILM COATED in 1 BOTTLE (47335-712-13) | 2014-12-15 | 0000-00-00 | No | No | Current |
| 47335-712-18 | 47335071218 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-712-18) | 2014-12-15 | 0000-00-00 | No | No | Current |
| 47335-712-83 | 47335071283 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-712-83) | 2014-12-15 | 0000-00-00 | No | No | Current |
| 47335-712-86 | 47335071286 | 60 TABLET, FILM COATED in 1 BOTTLE (47335-712-86) | 2014-12-15 | 0000-00-00 | No | No | Current |
| 47335-712-88 | 47335071288 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-712-88) | 2014-12-15 | 0000-00-00 | No | No | Current |