Simponi
- Product NDC
- 57894-071
- 11-digit product format
- 578940071
- Labeler code
- 57894
- Product ID
- 57894-071_02ee9cf4-c6d6-4239-854e-7c5976977456
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- golimumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Janssen Biotech, Inc.
- Application
- BLA125289
- Marketing category
- BLA
- Marketing start
- 2013-05-15
- Substance
- GOLIMUMAB
- Active strength
- 100 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
- Simponi
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GOLIMUMAB | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 91X1KLU43E |
| Rxcui | 848160, 848164, 1482813, 1482814, 1653142, 1653144, 1653165, 1653166 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57894-071-01 | Simponi | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 42 |
| 57894-071-01 | Simponi | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 42 |
| 57894-071-02 | Simponi | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 42 |
| 57894-071-02 | Simponi | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 42 |
| 57894-071-89 | Simponi | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 42 |
| 57894-071-89 | Simponi | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 42 |
| 57894-071-90 | Simponi | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 42 |
| 57894-071-90 | Simponi | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 42 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| golimumab | ACTIVE INGREDIENT | 91X1KLU43E | SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 18 | |
| golimumab | ACTIVE MOIETY | 91X1KLU43E | SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 18 | |
| Histidine | INACTIVE INGREDIENT | 4QD397987E | SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 18 | |
| Histidine Monohydrochloride Monohydrate | INACTIVE INGREDIENT | X573657P6P | SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 18 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 18 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 18 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 18 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57894-071 | SIMPONI (GOLIMUMAB) INJECTION, SOLUTION [JANSSEN BIOTECH, INC.] | 36 | Current NDC, Legacy NDC, 8 package rows | 20250429_f86cb4a7-c358-4136-ae57-b32bda9bba00.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57894-071-01 | 57894007101 | 1 SYRINGE, GLASS in 1 CARTON (57894-071-01) / 1 mL in 1 SYRINGE, GLASS | | 2013-05-15 | 0000-00-00 | No | No | Current |
| 57894-071-02 | 57894007102 | 1 SYRINGE in 1 CARTON (57894-071-02) / 1 mL in 1 SYRINGE | 1 syringe | 2013-05-15 | 0000-00-00 | No | No | Current |
| 57894-071-89 | 57894007189 | 1 SYRINGE in 1 CARTON (57894-071-89) / 1 mL in 1 SYRINGE | 1 syringe | 2013-05-15 | 0000-00-00 | No | No | Current |
| 57894-071-90 | 57894007190 | 1 SYRINGE, GLASS in 1 CARTON (57894-071-90) / 1 mL in 1 SYRINGE, GLASS | | 2013-05-15 | 0000-00-00 | No | No | Current |