Evenity
- Product NDC
- 55513-509
- 11-digit product format
- 555130509
- Labeler code
- 55513
- Product ID
- 55513-509_ce745f36-d616-4542-b53a-ad52407d1f8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- romosozumab-aqqg
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Amgen, Inc
- Application
- BLA761062
- Marketing category
- BLA
- Marketing start
- 2026-01-09
- Substance
- ROMOSOZUMAB
- Active strength
- 105 mg/1.17mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Evenity
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ROMOSOZUMAB | 105 mg/1.17mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 3VHF2ZD92J |
| Rxcui | 2123184, 2123185, 2123190, 2123191 |
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 |
| 9bd44bfd-2436-4701-a6e8-2952b9242f61 | Product name | 1 | 20190703 |
| 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 |
|---|---|---|---|---|---|---|
| 55513-509-01 | Evenity | 1.17 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1.17 | 17 | |
| 55513-509-02 | Evenity | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | 17 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2123191 | {2 (1.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled Syringe [Evenity]) } Pack [Evenity 210 MG Dose] | BPCK | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123185 | {2 (1.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled Syringe) } Pack | GPCK | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123190 | Evenity 105 MG in 1.17 mL Prefilled Syringe | PSN | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123191 | EVENITY 210 MG Dose Pack (2 count) | PSN | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123184 | romosozumab-aqqg 105 MG in 1.17 mL Prefilled Syringe | PSN | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123185 | romosozumab-aqqg 89.7 MG/ML in 1.17 ML Prefilled Syringe 2-Pack (210 MG Dose) | PSN | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123190 | 1.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled Syringe [Evenity] | SBD | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123184 | 1.17 ML romosozumab-aqqg 89.7 MG/ML Prefilled Syringe | SCD | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123190 | 1.17 ML Evenity 89.7 MG/ML Prefilled Syringe | SY | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123190 | Evenity 105 MG per 1.17 ML Prefilled Syringe | SY | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
| 2123191 | Evenity 210 MG Dose Pack (2 count) | SY | 471baba2-7154-4488-9891-0db2f46791e7 | 17 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55513-509-01 | 55513050901 | 1.17 mL in 1 SYRINGE, GLASS | 1.17 ml | Historical | |||
| 55513-509-02 | 55513050902 | 2 SYRINGE, GLASS in 1 CARTON (55513-509-02) / 1.17 mL in 1 SYRINGE, GLASS (55513-509-01) | 2026-01-09 | No | No | Current |