TOPIRAMATE
- Product NDC
- 61919-369
- 11-digit product format
- 619190369
- Labeler code
- 61919
- Product ID
- 61919-369_e9be4e26-9095-0486-e053-2a95a90a919e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TOPIRAMATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DirectRX
- Application
- ANDA076343
- Marketing category
- ANDA
- Marketing start
- 2020-05-12
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 |
|---|
| 61919-369-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 61919-369-72 | TOPIRAMATE | 120 in 1 BOTTLE | TABLET | 120 | | 6 |
| 61919-369-90 | TOPIRAMATE | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET, FILM COATED [DIRECTRX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-369 | TOPIRAMATE TABLET, FILM COATED TOPIRAMATE TABLET [DIRECTRX] | 6 | Legacy NDC, 3 package rows | 20230524_2082548c-371c-4c98-98a6-effe0a9bd2a4.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 |
|---|
| 61919-369-60 | 61919036960 | 60 TABLET in 1 BOTTLE (61919-369-60) | 60 tablet | 2020-05-12 | 0000-00-00 | No | No | Current |
| 61919-369-72 | 61919036972 | 120 TABLET in 1 BOTTLE (61919-369-72) | 120 tablet | 2020-05-12 | 0000-00-00 | No | No | Current |
| 61919-369-90 | 61919036990 | 90 TABLET in 1 BOTTLE (61919-369-90) | 90 tablet | 2020-05-12 | 0000-00-00 | No | No | Current |