Prescription drug · BLA
Enoby (Denosumab-qbde) NDC 0143-9165
Denosumab 60 mg/mL · Injection · Subcutaneous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9165-01 | 0014391650100143916501 | 1 SYRINGE in 1 CARTON (0143-9165-01) / 1 mL in 1 SYRINGEMarketed from Jan 8, 2026 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Enoby
- Generic name (nonproprietary)
- denosumab-qbde
- Active ingredients
- Denosumab — 60 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761439
- Marketing start
- Listing expires
- Other FDA classes
- RANK Ligand Blocking Activity (Mechanism)
- Identifiers
- Product ID 0143-9165_ddf6eb2a-4e1f-4cb4-992a-c93cbb5c0cfbSPL ID ddf6eb2a-4e1f-4cb4-992a-c93cbb5c0cfbSPL set ID 815d3ba4-27a1-4a06-925a-a87f35442bdbRxCUI 2725566, 2725573UNII 4EQZ6YO2HI
- Pharmacologic class
- RANK Ligand Inhibitor
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 codeMed-Code curated
J0897 — Injection, denosumab, 1 mg
Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.
Denosumab biosimilars have their own HCPCS codes.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400143916501followed by a unit qualifier and the quantityPackage 00143-9165-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Enoby is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Enoby is indicated for the treatment of…
Excerpt only. Read the full label for complete information.
About NDC 0143-9165
- What is NDC 0143-9165?
- 0143-9165 is the product NDC for Enoby (denosumab-qbde), Denosumab 60 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Enoby (Denosumab-qbde).
- What is the active ingredient?
- Denosumab.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Enoby?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Yes: J0897, Injection, denosumab, 1 mg. See Billing references above.
Other NDCs under BLA 761439
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 |
|---|---|---|---|---|
| Xtrenbodenosumab-qbde | Denosumab 120 mg/1.7mL | InjectionSubcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9166 |