RhoGAM Ultra-Filtered PLUS

UNIISPLATC J06BB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKedrion Biopharma Inc

CountryUS (United States)

ATC codeJ06BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0562780501
1 POUCH in 1 CARTON (0562-7805-01) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
ndc11
0562780505
5 POUCH in 1 CARTON (0562-7805-05) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)
ndc11
0562780525
25 POUCH in 1 CARTON (0562-7805-25) / 1 INJECTION, SOLUTION in 1 POUCH (0562-7805-00)

Annotations

UNII (FDA Substance ID)

48W7181FLP

HUMAN RHO(D) IMMUNE GLOBULIN

RxCUI 1789837

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "48W7181FLP",
    "rxcui": "1789837",
    "inchikey": null,
    "display_name": "HUMAN RHO(D) IMMUNE GLOBULIN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "d87e4d0b-2442-4135-b3f9-5c4f74845b87": {
      "match": "brand_token",
      "title": "RHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION MICRHOGAM ULTRA-FILTERED PLUS (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION BIOPHARMA INC]",
      "spl_version": "19",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0562-7805_7ccbaf67-ab6a-490a-9b63-598d75a7afca",
  "productndc": "0562-7805",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "HUMAN RHO(D) IMMUNE GLOBULIN",
  "proprietary_name": "RhoGAM Ultra-Filtered PLUS",
  "active_ingred_unit": "ug/1",
  "application_number": "BLA103777",
  "marketing_category": "BLA",
  "nonproprietary_name": "HUMAN RHO(D) IMMUNE GLOBULIN",
  "start_marketing_date": "20070309",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code J06BB01.

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