Sincalide

Product NDC
72266-248
11-digit product format
722660248
Labeler code
72266
Product ID
72266-248_187381ab-f66f-7a22-e063-6294a90a262a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sincalide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
FOSUN PHARMA USA INC
Application
NDA210850
Marketing category
NDA
Marketing start
2023-01-09
Substance
SINCALIDE
Active strength
5 ug/5mL
Pharmacologic classes
Cholecystokinin Analog [EPC], Cholecystokinin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sincalide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SINCALIDE5 ug/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM03GIQ7Z6P
Rxcui237982

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
957ff0e8-12af-4796-85ed-d1e36ea7fdc0Product name120230912
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-248-01Sincalide5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,53
72266-248-05Sincalide5 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-248-01EA - Each72266-248f04b83f6-6bb7-4754-a44b-d229ddb3aaed12023-06-06
72266-248-05EA - Each72266-248094030af-56d9-4a34-9a74-d20f2cde181912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-248SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC]3Current NDC, Legacy NDC, 2 package rows20240516_efbc189e-f5f8-0ac7-e053-2995a90a68a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237982sincalide 5 MCG InjectionPSNefbc189e-f5f8-0ac7-e053-2995a90a68a93
237982sincalide 0.005 MG InjectionSCDefbc189e-f5f8-0ac7-e053-2995a90a68a93
237982sincalide 5 MCG InjectionSYefbc189e-f5f8-0ac7-e053-2995a90a68a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-248-01722660248015 mL in 1 VIAL5 mlHistorical
72266-248-05722660248055 VIAL in 1 PACKAGE (72266-248-05) / 5 mL in 1 VIAL (72266-248-01) 5 vial2023-01-090000-00-00NoNoCurrent