sincalide

Generic: sincalide

Labeler: maia pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sincalide
Generic Name sincalide
Labeler maia pharmaceuticals, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sincalide 5 ug/5mL

Manufacturer
MAIA Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70511-131
Product ID 70511-131_f79a9ced-87d3-4e83-af8c-1451fcec4520
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210850
Listing Expiration 2026-12-31
Marketing Start 2022-11-25

Pharmacologic Class

Established (EPC)
cholecystokinin analog [epc]
Chemical Structure
cholecystokinin [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70511131
Hyphenated Format 70511-131

Supplemental Identifiers

RxCUI
237982
UNII
M03GIQ7Z6P
NUI
M0004235 N0000175798

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 sincalide (source: ndc)
Generic Name sincalide (source: ndc)
Application Number NDA210850 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 ug/5mL
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (70511-131-84) / 5 mL in 1 VIAL (70511-131-05)
source: ndc

Packages (1)

70511-131-84 10 VIAL in 1 PACKAGE (70511-131-84) / 5 mL in 1 VIAL (70511-131-05)

Ingredients (1)

sincalide (5 ug/5mL)

Linked Drug Pages (1)

Sincalide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f79a9ced-87d3-4e83-af8c-1451fcec4520", "openfda": {"nui": ["M0004235", "N0000175798"], "unii": ["M03GIQ7Z6P"], "rxcui": ["237982"], "spl_set_id": ["4149af34-7b3d-4200-9609-ea856b1d6aab"], "pharm_class_cs": ["Cholecystokinin [CS]"], "pharm_class_epc": ["Cholecystokinin Analog [EPC]"], "manufacturer_name": ["MAIA Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (70511-131-84)  / 5 mL in 1 VIAL (70511-131-05)", "package_ndc": "70511-131-84", "marketing_start_date": "20221125"}], "brand_name": "Sincalide", "product_id": "70511-131_f79a9ced-87d3-4e83-af8c-1451fcec4520", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cholecystokinin Analog [EPC]", "Cholecystokinin [CS]"], "product_ndc": "70511-131", "generic_name": "Sincalide", "labeler_name": "MAIA Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sincalide", "active_ingredients": [{"name": "SINCALIDE", "strength": "5 ug/5mL"}], "application_number": "NDA210850", "marketing_category": "NDA", "marketing_start_date": "20221125", "listing_expiration_date": "20261231"}