Nplate
- Product NDC
- 55513-223
- 11-digit product format
- 555130223
- Labeler code
- 55513
- Product ID
- 55513-223_74d31919-0ed2-4e98-abd8-7cc3e011646b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- romiplostim
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Amgen, Inc
- Application
- BLA125268
- Marketing category
- BLA
- Marketing start
- 2019-08-02
- Substance
- ROMIPLOSTIM
- Active strength
- 125 ug/.25mL
- Pharmacologic classes
- Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nplate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ROMIPLOSTIM | 125 ug/.25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GN5XU2DXKV |
| Rxcui | 1728092, 1728095, 1728097, 1728099, 2201538, 2201540 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55513-223-01 | Nplate | 0.25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 0.25 | | 161 |
| 55513-223-01 | Nplate | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 161 |
| 55513-223-21 | Nplate | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 161 |
| 55513-223-21 | Nplate | 0.25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 0.25 | | 161 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROMIPLOSTIM | ACTIVE INGREDIENT | GN5XU2DXKV | NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC] | 124 | |
| ROMIPLOSTIM | ACTIVE MOIETY | GN5XU2DXKV | NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC] | 124 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC] | 124 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC] | 124 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC] | 124 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC] | 124 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC] | 124 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55513-223 | NPLATE (ROMIPLOSTIM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN, INC] | 159 | Current NDC, Legacy NDC, 4 package rows | 20250309_c45f9a58-37c1-4f76-8e36-97d38c577037.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55513-223-01 | 55513022301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-01) / .25 mL in 1 VIAL, SINGLE-DOSE | 2019-08-02 | 0000-00-00 | No | No | Current |
| 55513-223-21 | 55513022321 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-21) / .25 mL in 1 VIAL, SINGLE-DOSE | 2025-08-01 | | No | No | Historical |