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United States · US · US:67457-675_ebb1716e-a4f1-42c4-82ac-ba5c062cfba0
Miacalcin
Orange BookUNIISPLATC H05BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeH05BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167457675021 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) / 2 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
7SFC6U2VI5
CALCITONIN SALMON
RxCUI 36118
Orange Book
N017808
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": {
"753ecc6a-07be-4fc6-9032-cc6ad116a662": {
"match": "brand_token",
"title": "MIACALCIN (CALCITONIN SALMON) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
"spl_version": "4",
"published_date": "2025-07-31"
}
},
"productid": "67457-675_ebb1716e-a4f1-42c4-82ac-ba5c062cfba0",
"productndc": "67457-675",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "017808",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Jul 3, 1986"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "200 IU/ML",
"product_no": "002",
"approval_date": "Mar 29, 1991"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CALCITONIN SALMON",
"proprietary_name": "Miacalcin",
"active_ingred_unit": "[USP'U]/mL",
"application_number": "NDA017808",
"marketing_category": "NDA",
"nonproprietary_name": "calcitonin salmon",
"start_marketing_date": "20160916",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code H05BA01.
- CACALCIMARSANOFI-AVENTIS CANADA INC
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- GBCalcitonin (salmon) 100units/1ml solution for injection ampoulesAlliance Healthcare (Distribution) Ltd
- GBCalcitonin (salmon) 100units/1ml solution for injection ampoulesEssential Pharma Ltd
- GBCalcitonin (salmon) 100units/1ml solution for injection ampoulesA A H Pharmaceuticals Ltd
- GBCalcitonin (salmon) 400units/2ml solution for injection vialsAlliance 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
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