ERLOTINIB
- Product NDC
- 31722-263
- 11-digit product format
- 317220263
- Labeler code
- 31722
- Product ID
- 31722-263_1bca3db4-f885-5bed-e063-6294a90ae9fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ERLOTINIB
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA209267
- Marketing category
- ANDA
- Marketing start
- 2024-05-24
- 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 | 603203, 603206, 603208 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-263-30 | ERLOTINIB | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 31722-263-30 | ERLOTINIB | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-263 | ERLOTINIB (ERLOTINIB) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20240710_a3b2d622-b4d5-4819-862b-f8fd3adcec6f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-263-30 | 31722026330 | 1 BOTTLE in 1 CARTON (31722-263-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2024-05-24 | No | No | Historical |