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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

  • ndc11
    1012255028
    4 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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