NDC 0093-5417 – Clozapine
Clozapine 25 mg/1 · Tablet, Orally Disintegrating · Oral
Product NDC0093-5417
Product details
- Brand name
- Clozapine
- Generic name
- Clozapine
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Dosage form
- Tablet, Orally Disintegrating
- Route
- Oral
- Marketing category
- ANDA · ANDA090308
- Marketed since
- July 25, 2017
- Listing expires
- December 31, 2026
- Pharmacologic class
- Atypical Antipsychotic
Active ingredients
- Clozapine 25 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0093-5417-01 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5417-01) | Jul 25, 2017 |
| 0093-5417-84 | 48 BLISTER PACK in 1 CARTON (0093-5417-84) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5417-19) | Jul 25, 2017 |
Recalls mentioning this NDC
- D-0001-2019 Oct 10, 2018 · Class II
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Other Clozapine products
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- 59651-261 Clozapine 25 mg/1 · Tablet, Orally Disintegrating · Aurobindo Pharma Limited
- 59651-260 Clozapine 12.5 mg/1 · Tablet, Orally Disintegrating · Aurobindo Pharma Limited
- 59651-262 Clozapine 100 mg/1 · Tablet, Orally Disintegrating · Aurobindo Pharma Limited
- 51079-288 Clozapine 100 mg/1 · Tablet, Orally Disintegrating · Mylan Institutional Inc.
- 0378-3813 Clozapine 25 mg/1 · Tablet, Orally Disintegrating · Mylan Pharmaceuticals Inc.
- 0378-3815 Clozapine 100 mg/1 · Tablet, Orally Disintegrating · Mylan Pharmaceuticals Inc.
- 0378-3816 Clozapine 150 mg/1 · Tablet, Orally Disintegrating · Mylan Pharmaceuticals Inc.
- 0378-3817 Clozapine 200 mg/1 · Tablet, Orally Disintegrating · Mylan Pharmaceuticals Inc.
- 48433-022 Clozapine 100 mg/1 · Tablet, Orally Disintegrating · Safecor Health, LLC
- 0093-5377 Clozapine 200 mg/1 · Tablet, Orally Disintegrating · Teva Pharmaceuticals USA, Inc.