Clozapine
- Product NDC
- 0378-3815
- 11-digit product format
- 003783815
- Labeler code
- 0378
- Product ID
- 0378-3815_435c523e-e4fc-4653-9eb7-ff9c194b42ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clozapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA201824
- Marketing category
- ANDA
- Marketing start
- 2015-11-02
- Substance
- CLOZAPINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clozapine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOZAPINE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J60AR2IKIC |
| Rxcui | 476177, 476179, 996921, 1006801 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-3815-01 | Clozapine | 100 in 1 BOTTLE, PLASTIC | TABLET, ORALLY DISINTEGRATING | 100 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLOZAPINE | ACTIVE INGREDIENT | J60AR2IKIC | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| CLOZAPINE | ACTIVE MOIETY | J60AR2IKIC | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-3815 | CLOZAPINE TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.] | 23 | Current NDC, Legacy NDC, 1 package rows | 20241127_9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-3815-01 | 00378381501 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3815-01) | 2015-11-02 | 0000-00-00 | No | No | Current |