Temozolomide
- Product NDC
- 43975-253
- 11-digit product format
- 439750253
- Labeler code
- 43975
- Product ID
- 43975-253_1d3dfef5-79f0-4761-b533-be6e9358eab1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temozolomide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA203490
- Marketing category
- ANDA
- Marketing start
- 2016-07-13
- Marketing end
- 0000-00-00
- Substance
- TEMOZOLOMIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA],Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 43975-253-05 | 43975025305 | 5 CAPSULE in 1 BOTTLE, GLASS (43975-253-05) | 5 capsule | 2016-07-13 | 0000-00-00 | No | No | Current |
| 43975-253-14 | 43975025314 | 14 CAPSULE in 1 BOTTLE, GLASS (43975-253-14) | 14 capsule | 2016-07-13 | 0000-00-00 | No | No | Current |