Topiramate
- Product NDC
- 10544-628
- 11-digit product format
- 105440628
- Labeler code
- 10544
- Product ID
- 10544-628_98f178c8-7659-4b64-afcd-755a7387addd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2014-01-22
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-628-90 | Topiramate | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| Polyethylene Glycol 400 | INACTIVE INGREDIENT | B697894SGQ | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| Polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| Sodium Starch Glycolate Type A Potato | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-628 | TOPIRAMATE TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20150217_98f178c8-7659-4b64-afcd-755a7387addd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-628-90 | 10544062890 | 90 in 1 BOTTLE | Historical |