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United States · US · US:25021-473_787c3f6a-788e-448f-b3ec-4541890f22fa
Calcitonin Salmon
Orange BookUNIISPLATC H05BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeH05BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1125021473021 VIAL in 1 CARTON (25021-473-02) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
7SFC6U2VI5
CALCITONIN SALMON
RxCUI 36118
Orange Book
A219196
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7SFC6U2VI5",
"rxcui": "36118",
"inchikey": null,
"display_name": "CALCITONIN SALMON",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; SUBCUTANEOUS",
"spl_meta": {
"2b8c6917-c217-45bf-a0ac-a2fa0f7d497a": {
"match": "brand_token",
"title": "CALCITONIN SALMON INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
"spl_version": "2",
"published_date": "2026-05-28"
}
},
"productid": "25021-473_787c3f6a-788e-448f-b3ec-4541890f22fa",
"productndc": "25021-473",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "219196",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "200 IU/ML",
"product_no": "001",
"approval_date": "Jul 9, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CALCITONIN SALMON",
"proprietary_name": "Calcitonin Salmon",
"active_ingred_unit": "[USP'U]/2mL",
"application_number": "ANDA219196",
"marketing_category": "ANDA",
"nonproprietary_name": "Calcitonin Salmon",
"start_marketing_date": "20250915",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code H05BA01.
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- GBCalcitonin (salmon) 100units/1ml solution for injection ampoulesEssential Pharma Ltd
- GBCalcitonin (salmon) 100units/1ml solution for injection ampoulesA A H Pharmaceuticals Ltd
- GBCalcitonin (salmon) 100units/1ml solution for injection ampoulesAlliance Healthcare (Distribution) Ltd
- GBCalcitonin (salmon) 400units/2ml solution for injection vialsA A H Pharmaceuticals Ltd
- GBCalcitonin (salmon) 400units/2ml solution for injection vialsEssential Pharma Ltd
- GBCalcitonin (salmon) 400units/2ml solution for injection vialsAlliance Healthcare (Distribution) Ltd
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