ENSACOVE
- Product NDC
- 83076-1100
- 11-digit product format
- 830761100
- Labeler code
- 83076
- Product ID
- 83076-1100_17196ce1-224e-4359-ac54-39e035def74f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ensartinib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Xcovery Holdings, Inc.
- Application
- NDA218171
- Marketing category
- NDA
- Marketing start
- 2025-04-30
- Substance
- ENSARTINIB HYDROCHLORIDE
- Active strength
- 100 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ENSACOVE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENSARTINIB HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C2FR6VT1BQ |
| Rxcui | 2712634, 2712640, 2712642, 2712644 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83076-1100-6 | ENSACOVE | 60 in 1 BOTTLE | CAPSULE | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83076-1100 | ENSACOVE (ENSARTINIB) CAPSULE [XCOVERY HOLDINGS, INC.] | 3 | Current NDC, 1 package rows | 20250430_1e1b2f79-678a-472a-b924-66909c8a4b2e.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 |
|---|
| 83076-1100-6 | 83076110006 | 60 CAPSULE in 1 BOTTLE (83076-1100-6) | 60 capsule | 2025-04-30 | No | No | Current |