Erlotinib Hydrochloride
- Product NDC
- 0378-7131
- 11-digit product format
- 003787131
- Labeler code
- 0378
- Product ID
- 0378-7131_c91e4788-c25a-4cf4-ab7f-192b73e8fa25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- erlotinib hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA091002
- Marketing category
- ANDA
- Marketing start
- 2019-05-09
- Marketing end
- 2022-11-30
- Substance
- ERLOTINIB
- Active strength
- 25 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-7131-93 | 00378713193 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7131-93) | 2019-05-09 | 0000-00-00 | No | No | Current |