temozolomide
- Product NDC
- 68382-751
- 11-digit product format
- 683820751
- Labeler code
- 68382
- Product ID
- 68382-751_2da71848-9a09-45b2-820e-c43f37b0fe3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA206750
- Marketing category
- ANDA
- Marketing start
- 2017-10-26
- Marketing end
- 0000-00-00
- Substance
- TEMOZOLOMIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-751-67 | 68382075167 | 14 CAPSULE in 1 BOTTLE (68382-751-67) | 14 capsule | 2017-10-26 | 0000-00-00 | No | No | Current |
| 68382-751-96 | 68382075196 | 5 CAPSULE in 1 BOTTLE (68382-751-96) | 5 capsule | 2017-10-26 | 0000-00-00 | No | No | Current |