ENOBY
- Product NDC
- 0143-9165
- 11-digit product format
- 001439165
- Labeler code
- 0143
- Product ID
- 0143-9165_ddf6eb2a-4e1f-4cb4-992a-c93cbb5c0cfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Denosumab-qbde
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- BLA761439
- Marketing category
- BLA
- Marketing start
- 2026-01-08
- Substance
- DENOSUMAB
- Active strength
- 60 mg/mL
- Pharmacologic classes
- RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ENOBY
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DENOSUMAB | 60 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4EQZ6YO2HI |
| Rxcui | 2725566, 2725573 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 31f7a69c-73ae-42bf-97ee-e31040596ed6 | Product name | 1 | 20180423 |
| b45e2e3f-1908-4144-8fa5-6f481dea7435 | Product name | 1 | 20170721 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9165-01 | ENOBY | 1 mL in 1 SYRINGE | INJECTION | 1 | 5 | |
| 0143-9165-01 | ENOBY | 1 in 1 CARTON | INJECTION | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9165-01 | ML - Milliliter | 0143-9165 | bf993c23-2f63-4524-b931-1945e0156baf | 1 | 2026-02-05 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2725566 | denosumab-qbde 60 MG in 1 ML Prefilled Syringe | PSN | 815d3ba4-27a1-4a06-925a-a87f35442bdb | 5 |
| 2725573 | Enoby 60 MG in 1 ML Prefilled Syringe | PSN | 815d3ba4-27a1-4a06-925a-a87f35442bdb | 5 |
| 2725573 | 1 ML denosumab-qbde 60 MG/ML Prefilled Syringe [Enoby] | SBD | 815d3ba4-27a1-4a06-925a-a87f35442bdb | 5 |
| 2725566 | 1 ML denosumab-qbde 60 MG/ML Prefilled Syringe | SCD | 815d3ba4-27a1-4a06-925a-a87f35442bdb | 5 |
| 2725573 | 1 ML Enoby 60 MG/ML Prefilled Syringe | SY | 815d3ba4-27a1-4a06-925a-a87f35442bdb | 5 |
| 2725566 | denosumab-qbde 60 MG per 1 ML Prefilled Syringe | SY | 815d3ba4-27a1-4a06-925a-a87f35442bdb | 5 |
| 2725573 | Enoby 60 MG per 1 ML Prefilled Syringe | SY | 815d3ba4-27a1-4a06-925a-a87f35442bdb | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0143-9165-01 | 00143916501 | 1 SYRINGE in 1 CARTON (0143-9165-01) / 1 mL in 1 SYRINGE | 1 syringe | 2026-01-08 | No | No | Historical |