Topiramate
- Product NDC
- 68084-343
- 11-digit product format
- 680840343
- Labeler code
- 68084
- Product ID
- 68084-343_40052c1b-5558-373b-e063-6394a90ad7d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2019-11-08
- Substance
- TOPIRAMATE
- Active strength
- 50 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 | 50 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 |
|---|
| 68084-343-01 | Topiramate | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 19 |
| 68084-343-11 | Topiramate | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| 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 |
|---|
| 68084-343 | TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 18 | Current NDC, Legacy NDC, 2 package rows | 20241109_1af94c80-2b17-409a-98f6-ce00f942351d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68084-343-01 | 68084034301 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-343-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-343-11) | 100 blister pack | 2019-11-08 | 0000-00-00 | No | No | Current |
| 68084-343-11 | 68084034311 | 1 in 1 BLISTER PACK | | | | | | Historical |