🇺🇸
United States · US · US:10122-550_84ca5e5f-886b-4216-b748-f7dad1201db0
Mycapssa
Orange BookUNIISPLATC H01CB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChiesi USA, Inc.
CountryUS (United States)
ATC codeH01CB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1110122550284 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
RWM8CCW8GP
OCTREOTIDE
RxCUI 7617
Orange Book
N208232
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RWM8CCW8GP",
"rxcui": "7617",
"inchikey": "DEQANNDTNATYII-OULOTJBUSA-N",
"display_name": "OCTREOTIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"58d80bc6-bdfb-4908-93e7-aace447c8d1a": {
"match": "brand_token",
"title": "MYCAPSSA (OCTREOTIDE) CAPSULE, DELAYED RELEASE [CHIESI USA, INC.]",
"spl_version": "6",
"published_date": "2025-07-28"
}
},
"productid": "10122-550_84ca5e5f-886b-4216-b748-f7dad1201db0",
"productndc": "10122-550",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "208232",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jun 26, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OCTREOTIDE",
"proprietary_name": "Mycapssa",
"active_ingred_unit": "mg/1",
"application_number": "NDA208232",
"marketing_category": "NDA",
"nonproprietary_name": "Octreotide",
"start_marketing_date": "20200706",
"active_numerator_strength": "20"
}Related drugs
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