CONEXXENCE
- Product NDC
- 65219-668
- 11-digit product format
- 652190668
- Labeler code
- 65219
- Product ID
- 65219-668_f778a079-d075-4205-bc94-8ec67e27c95e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Denosumab
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- BLA761398
- Marketing category
- BLA
- Marketing start
- 2025-06-30
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CONEXXENCE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DENOSUMAB | 60 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4EQZ6YO2HI |
| Rxcui | 2717531, 2717538 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a21a21e5-f36d-4c1f-8918-def921b8f7e3 | Product name | 3 | 20250124 |
| 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 |
|---|---|---|---|---|---|---|
| 65219-668-01 | CONEXXENCE | 1 in 1 CARTON | INJECTION | 1 | 3 | |
| 65219-668-01 | CONEXXENCE | 1 mL in 1 SYRINGE, PLASTIC | INJECTION | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-668-01 | ML - Milliliter | 65219-668 | 25cb093b-38cf-4510-8440-50ed0525a142 | 1 | 2025-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2717538 | Conexxence 60 MG in 1 ML Prefilled Syringe | PSN | 39a0a789-778f-4695-b3a9-61643e6396cd | 3 |
| 2717531 | denosumab-bnht 60 MG in 1 ML Prefilled Syringe | PSN | 39a0a789-778f-4695-b3a9-61643e6396cd | 3 |
| 2717538 | 1 ML denosumab-bnht 60 MG/ML Prefilled Syringe [Conexxence] | SBD | 39a0a789-778f-4695-b3a9-61643e6396cd | 3 |
| 2717531 | 1 ML denosumab-bnht 60 MG/ML Prefilled Syringe | SCD | 39a0a789-778f-4695-b3a9-61643e6396cd | 3 |
| 2717538 | Conexxence 60 MG per 1 ML Prefilled Syringe | SY | 39a0a789-778f-4695-b3a9-61643e6396cd | 3 |
| 2717538 | Conexxence 60 MG/ML per 1 ML Prefilled Syringe | SY | 39a0a789-778f-4695-b3a9-61643e6396cd | 3 |
| 2717531 | denosumab-bnht 60 MG per 1 ML Prefilled Syringe | SY | 39a0a789-778f-4695-b3a9-61643e6396cd | 3 |
| 2717531 | denosumab-bnht 60 MG/ML per 1 ML Prefilled Syringe | SY | 39a0a789-778f-4695-b3a9-61643e6396cd | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 65219-668-01 | 65219066801 | 1 SYRINGE, PLASTIC in 1 CARTON (65219-668-01) / 1 mL in 1 SYRINGE, PLASTIC | 2025-06-30 | No | No | Current |