Erlotinib
- Product NDC
- 51991-891
- 11-digit product format
- 519910891
- Labeler code
- 51991
- Product ID
- 51991-891_b2190c5f-7d87-4744-bcee-41bc2ee59b74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Erlotinib Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA208488
- Marketing category
- ANDA
- Marketing start
- 2019-11-05
- Marketing end
- 0000-00-00
- Substance
- ERLOTINIB HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-891 | ERLOTINIB (ERLOTINIB HYDROCHLORIDE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 3 | Legacy NDC | 20230202_3527fba1-a7d2-4c1c-99dc-ba53cec84994.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51991-891-33 | 51991089133 | 30 TABLET, FILM COATED in 1 BOTTLE (51991-891-33) | 2019-11-05 | 0000-00-00 | No | No | Current |