topiramate
- Product NDC
- 68382-141
- 11-digit product format
- 683820141
- Labeler code
- 68382
- Product ID
- 68382-141_48ba6ac8-7f36-4a5c-8055-295af6083862
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- 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 |
|---|
| 68382-141-01 | topiramate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 28 |
| 68382-141-05 | topiramate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 28 |
| 68382-141-14 | topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 28 |
| 68382-141-16 | topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 28 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 11 | |
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-141 | TOPIRAMATE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 26 | Current NDC, Legacy NDC, 4 package rows | 20250419_67dcdd6e-48bc-418e-a887-805929d83ce0.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 |
|---|
| 68382-141-01 | 68382014101 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-141-01) | 2009-03-27 | 0000-00-00 | No | No | Current |
| 68382-141-05 | 68382014105 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-141-05) | 2009-03-27 | 0000-00-00 | No | No | Current |
| 68382-141-14 | 68382014114 | 60 TABLET, FILM COATED in 1 BOTTLE (68382-141-14) | 2009-03-27 | 0000-00-00 | No | No | Current |
| 68382-141-16 | 68382014116 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-141-16) | 2009-03-27 | 0000-00-00 | No | No | Current |