Topiramate
- Product NDC
- 60429-769
- 11-digit product format
- 604290769
- Labeler code
- 60429
- Product ID
- 60429-769_be4e1a6e-ecdf-eb94-e053-2995a90a8a0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2011-07-08
- Marketing end
- 2022-05-31
- 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
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
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 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 |
|---|
| 60429-769-10 | 60429076910 | 1000 TABLET in 1 BOTTLE (60429-769-10) | 1000 tablet | 2011-07-08 | 0000-00-00 | No | No | Current |
| 60429-769-60 | 60429076960 | 60 TABLET in 1 BOTTLE (60429-769-60) | 60 tablet | 2011-07-08 | 0000-00-00 | No | No | Current |