Erlotinib Hydrochloride
- Product NDC
- 42292-052
- 11-digit product format
- 422920052
- Labeler code
- 42292
- Product ID
- 42292-052_b4dc994e-d507-2fc0-e053-2a95a90ae131
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- erlotinib hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA091002
- Marketing category
- ANDA
- Marketing start
- 2019-05-28
- Marketing end
- 2021-02-28
- Substance
- ERLOTINIB
- Active strength
- 100 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42292-052-05 | 42292005205 | 20 BLISTER PACK in 1 CARTON (42292-052-05) > 1 TABLET, FILM COATED in 1 BLISTER PACK (42292-052-01) | 20 blister pack | 2019-05-28 | 2021-02-28 | No | No | Current |