ZONISAMIDE
- Product NDC
- 61919-275
- 11-digit product format
- 619190275
- Labeler code
- 61919
- Product ID
- 61919-275_c4e749b0-47c2-4d50-abd1-8510c80934e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ZONISAMIDE
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- DirectRX
- Application
- ANDA077634
- Marketing category
- ANDA
- Marketing start
- 2015-01-01
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 61919-275-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-293d-f424-e053-dadaa90a57ce | ZONISAMIDE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-275-60 | ZONISAMIDE | 60 in 1 BOTTLE | CAPSULE | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-275-60 | EA - Each | 61919-275 | 700ff12a-119c-4d99-b5f3-4172aa7bcc18 | 1 | 2016-09-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ZONISAMIDE | ACTIVE INGREDIENT | 459384H98V | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| ZONISAMIDE | ACTIVE MOIETY | 459384H98V | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | ZONISAMIDE CAPSULE [DIRECTRX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZONISAMIDE CAPSULE [DIRECTRX] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403967 | zonisamide 50 MG Oral Capsule | PSN | 062ea00d-ba12-4667-a6e3-7d7a6d82bb7b | 1 |
| 403967 | zonisamide 50 MG Oral Capsule | SCD | 062ea00d-ba12-4667-a6e3-7d7a6d82bb7b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 61919-275-60 | 61919027560 | 60 in 1 BOTTLE | Historical |