TEMOZOLOMIDE
- Product NDC
- 64980-333
- 11-digit product format
- 649800333
- Labeler code
- 64980
- Product ID
- 64980-333_1c22f9d0-ae27-4e69-8b33-e634071128e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA206309
- Marketing category
- ANDA
- Marketing start
- 2017-03-17
- 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
- 2020-12-31
- 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 |
|---|
| 64980-333-05 | 64980033305 | 5 CAPSULE in 1 BOTTLE, PLASTIC (64980-333-05) | 5 capsule | 2017-03-17 | 0000-00-00 | No | No | Current |
| 64980-333-14 | 64980033314 | 14 CAPSULE in 1 BOTTLE, PLASTIC (64980-333-14) | 14 capsule | 2017-03-17 | 0000-00-00 | No | No | Current |