ZONISAMIDE
- Product NDC
- 61919-749
- 11-digit product format
- 619190749
- Labeler code
- 61919
- Product ID
- 61919-749_9cad9cfd-1021-0b1d-e053-2995a90a3f91
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZONISAMIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA077636
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- ZONISAMIDE
- Active strength
- 50 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 61919-749-60 | 2023-01-30 | C162847 | 48780-1 | f386c64a-2156-0266-e053-dadaa90a7c1a | ZONISAMIDE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-749-60 | ZONISAMIDE | 60 in 1 BOTTLE | CAPSULE | 60 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-749-60 | EA - Each | 61919-749 | a78f7e4e-24f9-4edc-ab95-c8a0088c9803 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ZONISAMIDE | ACTIVE INGREDIENT | 459384H98V | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| ZONISAMIDE | ACTIVE MOIETY | 459384H98V | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ZONISAMIDE CAPSULE [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZONISAMIDE CAPSULE [DIRECT RX] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403967 | zonisamide 50 MG Oral Capsule | PSN | fef69fd6-427e-40f1-98d1-47ec35cfbdc4 | 3 |
| 403967 | zonisamide 50 MG Oral Capsule | SCD | fef69fd6-427e-40f1-98d1-47ec35cfbdc4 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-749-60 | 61919074960 | 60 CAPSULE in 1 BOTTLE (61919-749-60) | 60 capsule | 2014-01-01 | 0000-00-00 | No | No | Current |