Clozapine
- Product NDC
- 16729-141
- 11-digit product format
- 167290141
- Labeler code
- 16729
- Product ID
- 16729-141_40aa4dd3-36ca-1132-e063-6394a90a268d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clozapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA202873
- Marketing category
- ANDA
- Marketing start
- 2017-04-10
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-141-01 | Clozapine | 100 in 1 BOTTLE | TABLET | 100 | | 16 |
| 16729-141-16 | Clozapine | 500 in 1 BOTTLE | TABLET | 500 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-141 | CLOZAPINE TABLET [ACCORD HEALTHCARE INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240718_25c0c6d5-f7b0-48e4-e054-00144ff8d46c.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 |
|---|
| 16729-141-01 | 16729014101 | 100 TABLET in 1 BOTTLE (16729-141-01) | 100 tablet | 2017-04-10 | 0000-00-00 | No | No | Current |
| 16729-141-16 | 16729014116 | 500 TABLET in 1 BOTTLE (16729-141-16) | 500 tablet | 2017-06-08 | 0000-00-00 | No | No | Current |