Cimzia
- Product NDC
- 50474-710
- 11-digit product format
- 504740710
- Labeler code
- 50474
- Product ID
- 50474-710_4b984e6f-72ac-4fdc-e063-6394a90af105
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- certolizumab pegol
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- UCB, Inc.
- Application
- BLA125160
- Marketing category
- BLA
- Marketing start
- 2009-05-14
- Substance
- CERTOLIZUMAB PEGOL
- Active strength
- 200 mg/mL
- Pharmacologic classes
- Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cimzia
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CERTOLIZUMAB PEGOL | 200 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UMD07X179E |
| Rxcui | 795081, 795085, 849597, 849599, 2724369, 2724370, 2724371, 2724372 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50474-710-79 | Cimzia | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 47 |
| 50474-710-79 | Cimzia | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 47 |
| 50474-710-80 | Cimzia | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 47 |
| 50474-710-80 | Cimzia | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 47 |
| 50474-710-81 | Cimzia | 3 in 1 BOX | INJECTION, SOLUTION | 3 | | 47 |
| 50474-710-81 | Cimzia | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 47 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50474-710 | CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.] | 39 | Current NDC, Legacy NDC, 6 package rows | 20250302_b4c2c9dc-a0bb-4d64-a667-a67ebe88392d.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2724370 | {2 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]) } Pack [Cimzia (2 count)] | BPCK | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724372 | {6 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]) } Pack [Cimzia Starter Kit (6 count)] | BPCK | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724369 | {2 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe) } Pack | GPCK | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724371 | {6 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe) } Pack | GPCK | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 849597 | certolizumab pegol 200 MG in 1 ML Prefilled Syringe | PSN | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724369 | certolizumab pegol 200 MG in 1 ML Prefilled Syringe, 2 count | PSN | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724371 | certolizumab pegol 200 MG in 1 ML Prefilled Syringe, 6 count | PSN | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 795081 | certolizumab pegol 200 MG Injection | PSN | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 849599 | Cimzia 200 MG in 1 ML Prefilled Syringe | PSN | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 795085 | Cimzia 200 MG Injection | PSN | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724370 | Cimzia Prefilled Syringe, 2 count | PSN | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724372 | Cimzia Starter Kit, 6 count | PSN | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 849599 | 1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia] | SBD | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 795085 | certolizumab pegol 200 MG Injection [Cimzia] | SBD | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 849597 | 1 ML certolizumab pegol 200 MG/ML Prefilled Syringe | SCD | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 795081 | certolizumab pegol 200 MG Injection | SCD | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 849599 | 1ML Cimzia 200 MG/ML Prefilled Syringe | SY | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 849597 | certolizumab pegol 200 MG per 1 ML Prefilled Syringe | SY | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724369 | certolizumab pegol 200 MG per 1 ML Prefilled Syringe, 2 count | SY | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724371 | certolizumab pegol 200 MG per 1 ML Prefilled Syringe, 6 count | SY | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 795085 | Cimzia 200 MG Injection | SY | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 849599 | Cimzia 200 MG per 1 ML Prefilled Syringe | SY | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724370 | Cimzia Prefilled Syringe, 2 count | SY | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
| 2724372 | Cimzia Starter Kit, 6 count | SY | b4c2c9dc-a0bb-4d64-a667-a67ebe88392d | 47 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50474-710-79 | 50474071079 | 2 SYRINGE, GLASS in 1 CARTON (50474-710-79) / 1 mL in 1 SYRINGE, GLASS | | 2009-05-14 | 0000-00-00 | No | No | Current |
| 50474-710-80 | 50474071080 | 2 SYRINGE, GLASS in 1 CARTON (50474-710-80) / 1 mL in 1 SYRINGE, GLASS | | 2009-05-14 | 0000-00-00 | Yes | No | Current |
| 50474-710-81 | 50474071081 | 3 CARTON in 1 BOX (50474-710-81) / 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS | 3 carton | 2009-05-14 | 0000-00-00 | No | No | Current |