Actemra
- Product NDC
- 50242-138
- 11-digit product format
- 502420138
- Labeler code
- 50242
- Product ID
- 50242-138_7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tocilizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Genentech, Inc.
- Application
- BLA125472
- Marketing category
- BLA
- Marketing start
- 2013-10-21
- Substance
- TOCILIZUMAB
- Active strength
- 162 mg/.9mL
- Pharmacologic classes
- Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Actemra
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOCILIZUMAB | 162 mg/.9mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | I031V2H011 |
| Rxcui | 1441527, 1441530, 1657974, 1657976, 1657979, 1657980, 1657981, 1657982, 2106073, 2106075 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9f5f0f3b-b458-45da-a406-00e2782d440a | Product name | 1 | 20150818 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50242-138-01 | Actemra | 0.9 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.9 | 53 | |
| 50242-138-01 | Actemra | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 53 | |
| 50242-138-86 | Actemra | 0.9 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.9 | 53 | |
| 50242-138-86 | Actemra | 1 in 1 BOX | INJECTION, SOLUTION | 1 | 53 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50242-138-01 | ML - Milliliter | 50242-138 | 7de8da37-de70-4de1-a874-e2f2fc087f41 | 1 | 2013-12-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50242-138 | ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION, CONCENTRATE ACTEMRA (TOCILIZUMAB) INJECTION, SOLUTION ACTEMRA ACTPEN (TOCILIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] | 50 | Current NDC, Legacy NDC, 4 package rows | 20241128_2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1441530 | Actemra 162 MG in 0.9 ML Prefilled Syringe | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657980 | Actemra 200 MG in 10 ML Injection | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657982 | Actemra 400 MG in 20 ML Injection | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657976 | Actemra 80 MG in 4 ML Injection | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 2106075 | Actemra ACTPen 162 MG in 0.9 ML Auto-Injector | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 2106073 | tocilizumab 162 MG in 0.9 ML Auto-Injector | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1441527 | tocilizumab 162 MG in 0.9 ML Prefilled Syringe | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657979 | tocilizumab 200 MG in 10 ML Injection | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657981 | tocilizumab 400 MG in 20 ML Injection | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657974 | tocilizumab 80 MG in 4 ML Injection | PSN | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 2106075 | 0.9 ML tocilizumab 180 MG/ML Auto-Injector [Actemra] | SBD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1441530 | 0.9 ML tocilizumab 180 MG/ML Prefilled Syringe [Actemra] | SBD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657980 | 10 ML tocilizumab 20 MG/ML Injection [Actemra] | SBD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657982 | 20 ML tocilizumab 20 MG/ML Injection [Actemra] | SBD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657976 | 4 ML tocilizumab 20 MG/ML Injection [Actemra] | SBD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 2106073 | 0.9 ML tocilizumab 180 MG/ML Auto-Injector | SCD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1441527 | 0.9 ML tocilizumab 180 MG/ML Prefilled Syringe | SCD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657979 | 10 ML tocilizumab 20 MG/ML Injection | SCD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657981 | 20 ML tocilizumab 20 MG/ML Injection | SCD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657974 | 4 ML tocilizumab 20 MG/ML Injection | SCD | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 2106075 | 0.9 ML Actemra 180 MG/ML Auto-Injector | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1441530 | Actemra 162 MG per 0.9 ML Prefilled Syringe | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657980 | Actemra 200 MG per 10 ML Injection | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657982 | Actemra 400 MG per 20 ML Injection | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657976 | Actemra 80 MG per 4 ML Injection | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 2106075 | Actemra ACTPen 162 MG per 0.9 ML Auto-Injector | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 2106073 | tocilizumab 162 MG in 0.9 ML Auto-Injector | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1441527 | tocilizumab 162 MG per 0.9 ML Prefilled Syringe | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657979 | tocilizumab 200 MG per 10 ML Injection | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657981 | tocilizumab 400 MG per 20 ML Injection | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
| 1657974 | tocilizumab 80 MG per 4 ML Injection | SY | 2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13 | 53 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50242-138-01 | 50242013801 | 1 SYRINGE, GLASS in 1 BOX (50242-138-01) / .9 mL in 1 SYRINGE, GLASS | 2013-10-21 | 0000-00-00 | No | No | Current |
| 50242-138-86 | 50242013886 | 1 SYRINGE, GLASS in 1 BOX (50242-138-86) / .9 mL in 1 SYRINGE, GLASS | 2013-10-21 | 0000-00-00 | Yes | No | Current |