CLOZAPINE
- Product NDC
- 0904-7088
- 11-digit product format
- 009047088
- Labeler code
- 0904
- Product ID
- 0904-7088_3f7b2119-695f-4b57-b505-b07a8f9cc065
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLOZAPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA206433
- Marketing category
- ANDA
- Marketing start
- 2016-11-29
- 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, 429212 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7088-61 | CLOZAPINE | 100 in 1 CARTON | TABLET | 100 | | 5 |
| 0904-7088-61 | CLOZAPINE | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7088 | CLOZAPINE TABLET [MAJOR PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250402_9db7aefb-f607-4158-a310-181e631bc648.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 |
|---|
| 0904-7088-61 | 00904708861 | 100 BLISTER PACK in 1 CARTON (0904-7088-61) / 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2016-11-29 | 0000-00-00 | No | No | Current |