sincalide

Generic: sincalide

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sincalide
Generic Name sincalide
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

sincalide 5 ug/5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-579
Product ID 63323-579_7aa01e72-178a-4161-b41b-f05bc8eba1a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017697
Listing Expiration 2026-12-31
Marketing Start 2023-04-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323579
Hyphenated Format 63323-579

Supplemental Identifiers

RxCUI
237982
UPC
0363323579012
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 NDA017697 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 ug/5mL
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01)
source: ndc

Packages (1)

63323-579-05 10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01)

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": "7aa01e72-178a-4161-b41b-f05bc8eba1a0", "openfda": {"nui": ["M0004235", "N0000175798"], "upc": ["0363323579012"], "unii": ["M03GIQ7Z6P"], "rxcui": ["237982"], "spl_set_id": ["bb5057da-8568-49b9-947d-fab7d8d8f257"], "pharm_class_cs": ["Cholecystokinin [CS]"], "pharm_class_epc": ["Cholecystokinin Analog [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (63323-579-05)  / 5 mL in 1 VIAL (63323-579-01)", "package_ndc": "63323-579-05", "marketing_start_date": "20230401"}], "brand_name": "SINCALIDE", "product_id": "63323-579_7aa01e72-178a-4161-b41b-f05bc8eba1a0", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cholecystokinin Analog [EPC]", "Cholecystokinin [CS]"], "product_ndc": "63323-579", "generic_name": "sincalide", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SINCALIDE", "active_ingredients": [{"name": "SINCALIDE", "strength": "5 ug/5mL"}], "application_number": "NDA017697", "marketing_category": "NDA", "marketing_start_date": "20230401", "listing_expiration_date": "20261231"}