FDA.reportPublic FDA data

SINCALIDE

Product NDC
63323-579
11-digit product format
633230579
Labeler code
63323
Product ID
63323-579_7aa01e72-178a-4161-b41b-f05bc8eba1a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sincalide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA017697
Marketing category
NDA
Marketing start
2023-04-01
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
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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
63323-579-01SINCALIDE5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,53
63323-579-05SINCALIDE10 in 1 PACKAGEINJECTION, POWDER, LYOPHILIZED,103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-579-01EA - Each63323-5796dae431e-c79f-4283-8c6b-d0fae4feb60b12023-06-06
63323-579-05EA - Each63323-579d639c8ca-4661-4dae-8937-a7213621a94612023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-579SINCALIDE (SINCALIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]3Current NDC, 2 package rows20240131_bb5057da-8568-49b9-947d-fab7d8d8f257.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237982sincalide 5 MCG InjectionPSNbb5057da-8568-49b9-947d-fab7d8d8f2573
237982sincalide 0.005 MG InjectionSCDbb5057da-8568-49b9-947d-fab7d8d8f2573
237982sincalide 5 MCG InjectionSYbb5057da-8568-49b9-947d-fab7d8d8f2573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63323-579-01633230579015 mL in 1 VIAL5 mlHistorical
63323-579-056332305790510 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01) 10 vial2023-04-01NoNoHistorical