CLOZAPINE
- Product NDC
- 63629-2361
- 11-digit product format
- 636292361
- Labeler code
- 63629
- Product ID
- 63629-2361_41baa684-f0a3-4637-b6db-cf28aab76ba5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLOZAPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075713
- Marketing category
- ANDA
- Marketing start
- 2005-08-19
- Substance
- CLOZAPINE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 63629-2361_41baa684-f0a3-4637-b6db-cf28aab76ba5
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- CLOZAPINE
- Generic name
- CLOZAPINE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2005-08-19
- Marketing category
- ANDA
- Application number
- ANDA075713
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| CLOZAPINE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | J60AR2IKIC |
| Rxcui | 429212 |
| Spl Set Id | 9b035a6a-f5c1-43a8-9203-cc016dc6e422 |
| Manufacturer Name | Bryant Ranch Prepack |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| J60AR2IKIC | CLOZAPINE | 5786-21-0 | CLOZAPINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-2361-1 | 63629236101 | 100 TABLET in 1 BOTTLE (63629-2361-1) | 100 tablet | 2005-08-19 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| CLOZAPINE | Bryant Ranch Prepack | 2024-05-31 | HUMAN PRESCRIPTION DRUG LABEL | 106 |