Clozapine
- Product NDC
- 48433-025
- 11-digit product format
- 484330025
- Labeler code
- 48433
- Product ID
- 48433-025_4c992fd8-c815-bfb3-e063-6294a90a8e6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clozapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Safecor Health LLC
- Application
- ANDA075417
- Marketing category
- ANDA
- Marketing start
- 2026-02-23
- Substance
- CLOZAPINE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J60AR2IKIC |
| Rxcui | 197535, 197536, 309374 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-025-01 | Clozapine | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
| 48433-025-20 | Clozapine | 100 in 1 CARTON | TABLET | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-025-01 | 48433002501 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-025-20 | 48433002520 | 100 BLISTER PACK in 1 CARTON (48433-025-20) / 1 TABLET in 1 BLISTER PACK (48433-025-01) | 100 blister pack | 2026-02-23 | No | No | Historical |