Clozapine
- Product NDC
- 0093-5416
- 11-digit product format
- 000935416
- Labeler code
- 0093
- Product ID
- 0093-5416_1b735bc2-6341-40af-8696-e61621d91ee8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clozapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA090308
- Marketing category
- ANDA
- Marketing start
- 2018-04-17
- Substance
- CLOZAPINE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clozapine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOZAPINE | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J60AR2IKIC |
| Rxcui | 476177, 476179, 721773, 996921, 1006801 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-5416-01 | Clozapine | 100 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 100 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-5416 | CLOZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA, INC.] | 11 | Current NDC, Legacy NDC, 1 package rows | 20250309_6fccf4f7-2e30-4272-9800-225aaef20584.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 |
|---|
| 0093-5416-01 | 00093541601 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5416-01) | 2018-04-17 | 0000-00-00 | No | No | Current |