Temozolomide
- Product NDC
- 62559-923
- 11-digit product format
- 625590923
- Labeler code
- 62559
- Product ID
- 62559-923_ea20ab6a-6558-4114-8983-c8df85adff0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA203490
- Marketing category
- ANDA
- Marketing start
- 2020-11-16
- Marketing end
- 2023-02-28
- Substance
- TEMOZOLOMIDE
- Active strength
- 140 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62559-923-14 | 62559092314 | 1 BOTTLE, GLASS in 1 CARTON (62559-923-14) > 14 CAPSULE in 1 BOTTLE, GLASS | 2020-11-16 | 0000-00-00 | No | No | Current |
| 62559-923-51 | 62559092351 | 1 BOTTLE, GLASS in 1 CARTON (62559-923-51) > 5 CAPSULE in 1 BOTTLE, GLASS | 2020-11-16 | 0000-00-00 | No | No | Current |