TOPIRAMATE
- Product NDC
- 52959-994
- 11-digit product format
- 529590994
- Labeler code
- 52959
- Product ID
- 52959-994_7e3a6da2-f432-4a62-ab53-c305587b7726
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA079153
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 50 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 |
|---|
| 52959-994-02 | TOPIRAMATE | 120 in 1 BOTTLE | TABLET | 120 | | 3 |
| 52959-994-30 | TOPIRAMATE | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 52959-994-60 | TOPIRAMATE | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 52959-994-90 | TOPIRAMATE | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-994 | TOPIRAMATE ( TOPIRAMATE ) TABLET [H.J. HARKINS COMPANY, INC.] | 3 | Legacy NDC, 4 package rows | 20120120_546130a3-e5f2-422d-88f0-66de19540ecb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-994-02 | 52959099402 | 120 in 1 BOTTLE | Historical |
| 52959-994-30 | 52959099430 | 30 in 1 BOTTLE | Historical |
| 52959-994-60 | 52959099460 | 60 in 1 BOTTLE | Historical |
| 52959-994-90 | 52959099490 | 90 in 1 BOTTLE | Historical |