TOPIRAMATE
- Product NDC
- 21695-348
- 11-digit product format
- 216950348
- Labeler code
- 21695
- Product ID
- 21695-348_56145d1a-1c0c-4c39-951e-45b9f324abcb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 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 |
|---|
| 21695-348-30 | TOPIRAMATE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 21695-348-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 21695-348-90 | TOPIRAMATE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-348 | TOPIRAMATE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 3 package rows | 20110622_56145d1a-1c0c-4c39-951e-45b9f324abcb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-348-30 | 21695034830 | 30 in 1 BOTTLE | Historical |
| 21695-348-60 | 21695034860 | 60 in 1 BOTTLE | Historical |
| 21695-348-90 | 21695034890 | 90 in 1 BOTTLE | Historical |