Zonisamide
- Product NDC
- 68462-130
- 11-digit product format
- 684620130
- Labeler code
- 68462
- Product ID
- 68462-130_c00ccc2d-52c6-4a11-a310-d8db25ca3928
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zonisamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA077651
- Marketing category
- ANDA
- Marketing start
- 2006-01-30
- Substance
- ZONISAMIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Carbonic Anhydrase Inhibitors [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], P-Glycoprotein Inhibitors [MoA], Sulfonamides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zonisamide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZONISAMIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 459384H98V |
| Rxcui | 314285, 403966, 403967 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-130-01 | Zonisamide | 100 in 1 BOTTLE | CAPSULE | 100 | | 14 |
| 68462-130-05 | Zonisamide | 500 in 1 BOTTLE | CAPSULE | 500 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ZONISAMIDE | ACTIVE INGREDIENT | 459384H98V | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| ZONISAMIDE | ACTIVE MOIETY | 459384H98V | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 7 | |
| ZONISAMIDE | ACTIVE INGREDIENT | 459384H98V | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| ZONISAMIDE | ACTIVE INGREDIENT | 459384H98V | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| ZONISAMIDE | ACTIVE MOIETY | 459384H98V | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| ZONISAMIDE | ACTIVE MOIETY | 459384H98V | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIRECT RX (ZONISAMIDE) CAPSULE [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZONISAMIDE CAPSULE [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-130 | ZONISAMIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 13 | Current NDC, Legacy NDC, 2 package rows | 20220928_fe15e56e-8b86-4a65-825c-31d37dd81612.zip |
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 |
|---|
| 68462-130-01 | 68462013001 | 100 CAPSULE in 1 BOTTLE (68462-130-01) | 100 capsule | 2006-01-30 | 0000-00-00 | No | No | Current |
| 68462-130-05 | 68462013005 | 500 CAPSULE in 1 BOTTLE (68462-130-05) | 500 capsule | 2006-01-30 | 0000-00-00 | No | No | Current |