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NDC 00562-7805-25 RhoGAM Ultra-Filtered PLUS 300 ug/1 Details
RhoGAM Ultra-Filtered PLUS 300 ug/1
RhoGAM Ultra-Filtered PLUS is a INTRAMUSCULAR INJECTION, SOLUTION in the PLASMA DERIVATIVE category. It is labeled and distributed by Kedrion Biopharma Inc. The primary component is HUMAN RHO(D) IMMUNE GLOBULIN.
Product Information
| NDC | 00562-7805 |
|---|---|
| Product ID | 0562-7805_658ecb5b-660d-411b-ae83-50af5b3b9302 |
| Associated GPIs | 1910005000E540 |
| GCN Sequence Number | 045802 |
| GCN Sequence Number Description | Rho(D) immune globulin SYRINGE 1500 UNIT INTRAMUSC |
| HIC3 | W7K |
| HIC3 Description | ANTISERA |
| GCN | 91398 |
| HICL Sequence Number | 004209 |
| HICL Sequence Number Description | RHO(D) IMMUNE GLOBULIN |
| Brand/Generic | Brand |
| Proprietary Name | RhoGAM Ultra-Filtered PLUS |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | HUMAN RHO(D) IMMUNE GLOBULIN |
| Product Type | PLASMA DERIVATIVE |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | ug/1 |
| Substance Name | HUMAN RHO(D) IMMUNE GLOBULIN |
| Labeler Name | Kedrion Biopharma Inc |
| Pharmaceutical Class | Endogenous Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA103777 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00562-7805-25 (00562780525)
| NDC Package Code | 0562-7805-25 |
|---|---|
| Billing NDC | 00562780525 |
| Package | 25 POUCH in 1 CARTON (0562-7805-25) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00) |
| Marketing Start Date | 2007-03-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |