Topiramate
- Product NDC
- 43063-605
- 11-digit product format
- 430630605
- Labeler code
- 43063
- Product ID
- 43063-605_dc038e1d-5328-1987-e053-2995a90a8404
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA077627
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 100 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-605 | TOPIRAMATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 23 | Legacy NDC | 20241013_b5fb741b-b13f-4ef2-9edc-2d4102efe056.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-605-30 | 43063060530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-605-30) | 2015-08-31 | 0000-00-00 | No | No | Current |
| 43063-605-60 | 43063060560 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-605-60) | 2015-08-31 | 0000-00-00 | No | No | Current |