mycapssa

Generic: octreotide

Labeler: chiesi usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mycapssa
Generic Name octreotide
Labeler chiesi usa, inc.
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

octreotide 20 mg/1

Manufacturer
Chiesi USA, Inc.

Identifiers & Regulatory

Product NDC 10122-550
Product ID 10122-550_84ca5e5f-886b-4216-b748-f7dad1201db0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208232
Listing Expiration 2026-12-31
Marketing Start 2020-07-06

Pharmacologic Class

Established (EPC)
somatostatin analog [epc]
Mechanism of Action
somatostatin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10122550
Hyphenated Format 10122-550

Supplemental Identifiers

RxCUI
2380611 2380617
UNII
RWM8CCW8GP
NUI
N0000175904 N0000000194

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mycapssa (source: ndc)
Generic Name octreotide (source: ndc)
Application Number NDA208232 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

10122-550-28 4 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

octreotide (20 mg/1)

Linked Drug Pages (1)

Mycapssa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "84ca5e5f-886b-4216-b748-f7dad1201db0", "openfda": {"nui": ["N0000175904", "N0000000194"], "unii": ["RWM8CCW8GP"], "rxcui": ["2380611", "2380617"], "spl_set_id": ["58d80bc6-bdfb-4908-93e7-aace447c8d1a"], "pharm_class_epc": ["Somatostatin Analog [EPC]"], "pharm_class_moa": ["Somatostatin Receptor Agonists [MoA]"], "manufacturer_name": ["Chiesi USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 DOSE PACK (10122-550-28)  / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "10122-550-28", "marketing_start_date": "20200706"}], "brand_name": "Mycapssa", "product_id": "10122-550_84ca5e5f-886b-4216-b748-f7dad1201db0", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Somatostatin Analog [EPC]", "Somatostatin Receptor Agonists [MoA]"], "product_ndc": "10122-550", "generic_name": "Octreotide", "labeler_name": "Chiesi USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mycapssa", "active_ingredients": [{"name": "OCTREOTIDE", "strength": "20 mg/1"}], "application_number": "NDA208232", "marketing_category": "NDA", "marketing_start_date": "20200706", "listing_expiration_date": "20261231"}