Erlotinib
- Product NDC
- 72485-217
- 11-digit product format
- 724850217
- Labeler code
- 72485
- Product ID
- 72485-217_35e3a161-752e-4479-b27c-3dc8efd3ca9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Erlotinib hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA211960
- Marketing category
- ANDA
- Marketing start
- 2019-11-06
- Substance
- ERLOTINIB HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Erlotinib
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ERLOTINIB HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DA87705X9K |
| Rxcui | 603208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72485-217-30 | Erlotinib | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 72485-217-30 | Erlotinib | 1 in 1 BOX | TABLET, FILM COATED | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72485-217 | ERLOTINIB (ERLOTINIB HYDROCHLORIDE) TABLET, FILM COATED [ARMAS PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20191110_53cf8868-cfd8-4c6e-ad9d-3171ff1e4d8c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72485-217-30 | 72485021730 | 1 BOTTLE in 1 BOX (72485-217-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-11-06 | 0000-00-00 | No | No | Current |