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United States · US · US:71336-1001_942492a0-de6e-4c31-8b9c-d259f808d821
GIVLAARI
Orange BookUNIISPLATC A16AX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlnylam Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA16AX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171336100111 VIAL, SINGLE-USE in 1 CARTON (71336-1001-1) / 1 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
5XE21E41RT
GIVOSIRAN SODIUM
RxCUI 2265859
Orange Book
N212194
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "5XE21E41RT",
"rxcui": "2265859",
"inchikey": null,
"display_name": "GIVOSIRAN SODIUM",
"substance_type": "nucleicAcid",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"167e663c-11e1-497b-a3fc-951d65d58eaa": {
"match": "brand_token",
"title": "GIVLAARI (GIVOSIRAN SODIUM) INJECTION, SOLUTION [ALNYLAM PHARMACEUTICALS, INC.]",
"spl_version": "14",
"published_date": "2025-09-22"
}
},
"productid": "71336-1001_942492a0-de6e-4c31-8b9c-d259f808d821",
"productndc": "71336-1001",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "212194",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 189MG BASE/ML (EQ 189MG BASE/ML)",
"product_no": "001",
"approval_date": "Nov 20, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GIVOSIRAN SODIUM",
"proprietary_name": "GIVLAARI",
"active_ingred_unit": "mg/mL",
"application_number": "NDA212194",
"marketing_category": "NDA",
"nonproprietary_name": "givosiran sodium",
"start_marketing_date": "20191212",
"active_numerator_strength": "189"
}Related drugs
Other records sharing ATC code A16AX16.
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