Topiramate
- Product NDC
- 31722-281
- 11-digit product format
- 317220281
- Labeler code
- 31722
- Product ID
- 31722-281_6be89e4b-831c-46d6-a4c0-1c2ab53d2d22
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA079162
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 200 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 31722-281-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d17a-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 1996 |
| 31722-281-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d17a-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 1996 |
| 31722-281-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d17a-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use topiramate tablets, USP safely and effectively. See full prescribing information for topiramate tablets, USPTopiramate Tablets, USP for oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-281-05 | Topiramate | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
| 31722-281-10 | Topiramate | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
| 31722-281-60 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| TOPIRAMATE | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | |
| TOPIRAMATE | ACTIVE INGREDIENT | 0H73WJJ391 | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| Topiramate | ACTIVE MOIETY | 0H73WJJ391 | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOPIRAMATE TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-281 | TOPIRAMATE TABLET [CAMBER PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 3 package rows | 20151028_e999cb0a-8e45-4fdc-9b52-f3661f5dfc33.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 31722-281-05 | 31722028105 | 500 in 1 BOTTLE | Historical |
| 31722-281-10 | 31722028110 | 1000 in 1 BOTTLE | Historical |
| 31722-281-60 | 31722028160 | 60 in 1 BOTTLE | Historical |