Prescription drug · NDA
Ensacove (Ensartinib) NDC 83076-1100
Ensartinib hydrochloride 100 mg/1 · Capsule · Oral · Xcovery Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83076-1100-6 | 83076110006 | 60 CAPSULE in 1 BOTTLE (83076-1100-6)Marketed from Apr 30, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ensacove
- Generic name (nonproprietary)
- ensartinib
- Active ingredients
- Ensartinib hydrochloride — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Xcovery Holdings, Inc.NDC labeler code 83076
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218171
- Marketing start
- Listing expires
- Identifiers
- Product ID 83076-1100_17196ce1-224e-4359-ac54-39e035def74fSPL ID 17196ce1-224e-4359-ac54-39e035def74fSPL set ID 1e1b2f79-678a-472a-b924-66909c8a4b2eRxCUI 2712634, 2712640, 2712642, 2712644UNII C2FR6VT1BQUPC 0383076102534
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483076110006followed by a unit qualifier and the quantityPackage 83076-1100-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor. ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor. ( 1 , 2.1 )
Excerpt only. Read the full label for complete information.
About NDC 83076-1100
- What is NDC 83076-1100?
- 83076-1100 is the product NDC for Ensacove (ensartinib), Ensartinib hydrochloride 100 mg/1 capsule, listed with the FDA by Xcovery Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ensacove (Ensartinib).
- What is the active ingredient?
- Ensartinib hydrochloride.
- Who is the labeler?
- Xcovery Holdings, Inc., NDC labeler code 83076. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ensacove?
- 1 other product NDC are listed under this name. See all Ensacove NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ensacove products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ensacoveensartinib | Ensartinib hydrochloride 25 mg/1 | CapsuleOral | Xcovery Holdings, Inc. | 83076-1025 | 83076-1025-03 |
Other NDCs under NDA 218171
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ensacoveensartinib | Ensartinib hydrochloride 25 mg/1 | CapsuleOral | Xcovery Holdings, Inc. | 83076-1025 |