Clozaril
- Product NDC
- 64725-1260
- 11-digit product format
- 647251260
- Labeler code
- 64725
- Product ID
- 64725-1260_089b76b6-71af-4893-bb1b-4890fcc4a3e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clozapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- NDA019758
- Marketing category
- NDA
- Marketing start
- 1989-09-30
- Marketing end
- 0000-00-00
- Substance
- CLOZAPINE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- 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 |
|---|---|---|---|
| fde12e54-43fa-cc16-3015-4c000a7b8d3e | Product name | 5 | 20250812 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 0901063f-b37f-4bf1-8be6-1e2a469e57bc | Product name | 2 | 20180209 |
| e01fb60f-a608-2c68-dfdd-23e6433ece68 | Product name | 5 | 20180209 |
| 7a7f58c4-be43-7e82-4dfc-128bbed4230a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64725-1260-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3d02-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use CLOZARIL safely and effectively. See full prescribing information for CLOZARIL. CLOZARIL® (clozapine) tablets, for oral use Initial U.S. Approval: 1989 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-1260-1 | Clozaril | 30 in 1 CONTAINER | TABLET | 30 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CLOZAPINE | ACTIVE INGREDIENT | J60AR2IKIC | CLOZARIL (CLOZAPINE) TABLET [TYA PHARMACEUTICALS] | 2 | |
| CLOZAPINE | ACTIVE MOIETY | J60AR2IKIC | CLOZARIL (CLOZAPINE) TABLET [TYA PHARMACEUTICALS] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | CLOZARIL (CLOZAPINE) TABLET [TYA PHARMACEUTICALS] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CLOZARIL (CLOZAPINE) TABLET [TYA PHARMACEUTICALS] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | CLOZARIL (CLOZAPINE) TABLET [TYA PHARMACEUTICALS] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLOZARIL (CLOZAPINE) TABLET [TYA PHARMACEUTICALS] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CLOZARIL (CLOZAPINE) TABLET [TYA PHARMACEUTICALS] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CLOZARIL (CLOZAPINE) TABLET [TYA PHARMACEUTICALS] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-1260 | CLOZARIL (CLOZAPINE) TABLET [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20140924_0cf63b13-48b2-4b07-b241-617725b52f6b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197536 | cloZAPine 25 MG Oral Tablet | PSN | 0cf63b13-48b2-4b07-b241-617725b52f6b | 2 |
| 104775 | Clozaril 25 MG Oral Tablet | PSN | 0cf63b13-48b2-4b07-b241-617725b52f6b | 2 |
| 104775 | clozapine 25 MG Oral Tablet [Clozaril] | SBD | 0cf63b13-48b2-4b07-b241-617725b52f6b | 2 |
| 197536 | clozapine 25 MG Oral Tablet | SCD | 0cf63b13-48b2-4b07-b241-617725b52f6b | 2 |
| 104775 | Clozaril 25 MG Oral Tablet | SY | 0cf63b13-48b2-4b07-b241-617725b52f6b | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-1260-1 | 64725126001 | 30 in 1 CONTAINER | Historical |