CLOZAPINE
- Product NDC
- 65862-844
- 11-digit product format
- 658620844
- Labeler code
- 65862
- Product ID
- 65862-844_a46da176-2ed3-4b9a-b06f-efab2936a5ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLOZAPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206433
- Marketing category
- ANDA
- Marketing start
- 2016-11-29
- Substance
- CLOZAPINE
- Active strength
- 25 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 | 25 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 |
|---|
| 65862-844-01 | CLOZAPINE | 100 in 1 BOTTLE | TABLET | 100 | | 15 |
| 65862-844-05 | CLOZAPINE | 500 in 1 BOTTLE | TABLET | 500 | | 15 |
| 65862-844-10 | CLOZAPINE | 10 in 1 BLISTER PACK | TABLET | 10 | | 15 |
| 65862-844-78 | CLOZAPINE | 10 in 1 CARTON | TABLET | 10 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-844 | CLOZAPINE TABLET [AUROBINDO PHARMA LIMITED] | 13 | Current NDC, Legacy NDC, 4 package rows | 20250306_5021d643-32d2-4167-b5d8-90870e68a787.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 |
|---|
| 65862-844-01 | 65862084401 | 100 TABLET in 1 BOTTLE (65862-844-01) | 100 tablet | 2016-11-29 | 0000-00-00 | No | No | Current |
| 65862-844-05 | 65862084405 | 500 TABLET in 1 BOTTLE (65862-844-05) | 500 tablet | 2016-11-29 | 0000-00-00 | No | No | Current |
| 65862-844-10 | 65862084410 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 65862-844-78 | 65862084478 | 10 BLISTER PACK in 1 CARTON (65862-844-78) / 10 TABLET in 1 BLISTER PACK (65862-844-10) | 10 blister pack | 2016-11-29 | 0000-00-00 | No | No | Current |