Stoboclo
- Product NDC
- 72606-037
- 11-digit product format
- 726060037
- Labeler code
- 72606
- Product ID
- 72606-037_a1cd4ff2-cdab-41fa-b8f5-e2bc0faea49f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- denosumab-bmwo
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- CELLTRION USA, Inc.
- Application
- BLA761404
- Marketing category
- BLA
- Marketing start
- 2025-07-02
- 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
- Stoboclo
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DENOSUMAB | 60 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4EQZ6YO2HI |
| Rxcui | 2717855, 2717862 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 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 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72606-037-01 | Stoboclo | 1 in 1 CARTON | INJECTION | 1 | 7 | |
| 72606-037-01 | Stoboclo | 1 mL in 1 SYRINGE | INJECTION | 1 | 7 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2717855 | denosumab-bmwo 60 MG in 1 ML Prefilled Syringe | PSN | 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 7 |
| 2717862 | Stoboclo 60 MG in 1 ML Prefilled Syringe | PSN | 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 7 |
| 2717862 | 1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe [Stoboclo] | SBD | 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 7 |
| 2717855 | 1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe | SCD | 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 7 |
| 2717862 | 1 ML Stoboclo 60 MG/ML Prefilled Syringe | SY | 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 7 |
| 2717855 | denosumab-bmwo 60 MG per 1 ML Prefilled Syringe | SY | 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 7 |
| 2717862 | Stoboclo 60 MG per 1 ML Prefilled Syringe | SY | 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72606-037-01 | 72606003701 | 1 SYRINGE in 1 CARTON (72606-037-01) / 1 mL in 1 SYRINGE | 1 syringe | 2025-07-02 | No | No | Current |