Clozapine
- Product NDC
- 48433-022
- 11-digit product format
- 484330022
- Labeler code
- 48433
- Product ID
- 48433-022_4cedfa23-a6bd-ddf7-e063-6294a90aa994
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clozapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- ANDA201824
- Marketing category
- ANDA
- Marketing start
- 2026-03-05
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-022-01 | Clozapine | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 1 | | 2 |
| 48433-022-04 | Clozapine | 40 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 40 | | 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 |
|---|
| 48433-022-01 | 48433002201 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-022-04 | 48433002204 | 40 BLISTER PACK in 1 CARTON (48433-022-04) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (48433-022-01) | 40 blister pack | 2026-03-05 | No | No | Historical |