ZONISAMIDE
- Product NDC
- 64679-945
- 11-digit product format
- 646790945
- Labeler code
- 64679
- Product ID
- 64679-945_45429c50-70bd-4f75-8715-62ec39ee5192
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZONISAMIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- Application
- ANDA077636
- Marketing category
- ANDA
- Marketing start
- 2006-07-27
- Marketing end
- 0000-00-00
- Substance
- ZONISAMIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 4ca446c7-87bf-4d4c-9a5f-4c587ab0290f | Product name | 1 | 20230316 |
| c27132c2-a1b9-fc49-b84e-22e55312d19e | Product name | 2 | 20210621 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64679-945-01 | 2024-11-15 | C162847 | 48780-1 | 9d75b9d0-f304-f424-e053-dadaa90a57ce | b2433b54-da24-45c7-9d48-35f098e15814 |
| 64679-945-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-f304-f424-e053-dadaa90a57ce | b2433b54-da24-45c7-9d48-35f098e15814 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64679-945-01 | EA - Each | 64679-945 | 7483e784-b3fe-4357-940c-454b3e46bb9e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ZONISAMIDE | ACTIVE INGREDIENT | 459384H98V | ZONISAMIDE CAPSULE [STAT RX USA LLC] | 1 | |
| ZONISAMIDE | ACTIVE MOIETY | 459384H98V | ZONISAMIDE CAPSULE [STAT RX USA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZONISAMIDE CAPSULE [STAT RX USA LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZONISAMIDE CAPSULE [STAT RX USA LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZONISAMIDE CAPSULE [STAT RX USA LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ZONISAMIDE CAPSULE [STAT RX USA LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZONISAMIDE CAPSULE [STAT RX USA LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ZONISAMIDE CAPSULE [STAT RX USA LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZONISAMIDE CAPSULE [STAT RX USA LLC] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403966 | zonisamide 25 MG Oral Capsule | PSN | 0ab183cf-51aa-402a-9351-53a4f112d1f9 | 1 |
| 403966 | zonisamide 25 MG Oral Capsule | SCD | 0ab183cf-51aa-402a-9351-53a4f112d1f9 | 1 |