Clozapine
- Product NDC
- 0378-0860
- 11-digit product format
- 003780860
- Labeler code
- 0378
- Product ID
- 0378-0860_a8cef9ad-4bf9-4289-9473-400c8f1a95ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clozapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA075417
- Marketing category
- ANDA
- Marketing start
- 1999-07-08
- 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 | 197535, 197536, 309374, 429212 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-0860-01 | Clozapine | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 35 |
| 0378-0860-02 | Clozapine | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 35 |
| 0378-0860-05 | Clozapine | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 35 |
| 0378-0860-07 | Clozapine | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 35 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0860 | CLOZAPINE TABLET [MYLAN PHARMACEUTICALS INC.] | 32 | Current NDC, Legacy NDC, 4 package rows | 20250417_883b5d43-0339-7dc1-f775-93791fb9b978.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0860-01 | 00378086001 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0860-01) | 100 tablet | 1999-07-08 | 0000-00-00 | No | No | Current |
| 0378-0860-02 | 00378086002 | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0860-02) | 100 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |
| 0378-0860-05 | 00378086005 | 500 TABLET in 1 BOTTLE, PLASTIC (0378-0860-05) | 500 tablet | 2001-02-05 | 0000-00-00 | No | No | Current |
| 0378-0860-07 | 00378086007 | 500 TABLET in 1 BOTTLE, PLASTIC (0378-0860-07) | 500 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |