Topamax
- Product NDC
- 50458-645
- 11-digit product format
- 504580645
- Labeler code
- 50458
- Product ID
- 50458-645_1c7483cf-95db-4b1c-ae4c-b11bc95a6ad8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA020844
- Marketing category
- NDA
- Marketing start
- 1998-11-01
- Substance
- TOPIRAMATE
- Active strength
- 25 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topamax
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0H73WJJ391 |
| Rxcui | 151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, 845478, 845479 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50458-645-65 | Topamax | 60 in 1 BOTTLE | CAPSULE, COATED PELLETS | 60 | | 30 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| topiramate | ACTIVE INGREDIENT | 0H73WJJ391 | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| topiramate | ACTIVE MOIETY | 0H73WJJ391 | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| carnauba wax | INACTIVE INGREDIENT | R12CBM0EIZ | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| cellulose acetate | INACTIVE INGREDIENT | 3J2P07GVB6 | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| raw sugar | INACTIVE INGREDIENT | 8M707QY5GH | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| sodium starch glycolate type A potato | INACTIVE INGREDIENT | 5856J3G2A2 | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| sorbitan monolaurate | INACTIVE INGREDIENT | 6W9PS8B71J | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 14 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50458-645 | TOPAMAX (TOPIRAMATE) TABLET, COATED TOPAMAX (TOPIRAMATE) CAPSULE, COATED PELLETS [JANSSEN PHARMACEUTICALS, INC.] | 28 | Current NDC, Legacy NDC, 1 package rows | 20250326_21628112-0c47-11df-95b3-498d55d89593.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50458-645-65 | 50458064565 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50458-645-65) | 1998-11-01 | 0000-00-00 | No | No | Current |