topiramate
- Product NDC
- 29300-118
- 11-digit product format
- 293000118
- Labeler code
- 29300
- Product ID
- 29300-118_961973db-b7ab-40fa-ad75-4163738def9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA090162
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- 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 |
|---|
| 29300-118-01 | topiramate | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 20 |
| 29300-118-05 | topiramate | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 20 |
| 29300-118-10 | topiramate | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 20 |
| 29300-118-16 | topiramate | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 20 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-118 | TOPIRAMATE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.] | 19 | Current NDC, Legacy NDC, 4 package rows | 20250416_6ee00e82-799d-445e-b658-a9712c49a28e.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 |
|---|
| 29300-118-01 | 29300011801 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-118-01) | 2013-07-01 | 0000-00-00 | No | No | Current |
| 29300-118-05 | 29300011805 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-118-05) | 2013-07-01 | 0000-00-00 | No | No | Current |
| 29300-118-10 | 29300011810 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-118-10) | 2013-07-01 | 0000-00-00 | No | No | Current |
| 29300-118-16 | 29300011816 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-118-16) | 2013-07-01 | 0000-00-00 | No | No | Current |