Crenessity

Product NDC
70370-5250
11-digit product format
703705250
Labeler code
70370
Product ID
70370-5250_f5cc43fd-6e18-4a06-8c9f-bd80ea847e83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
crinecerfont
Dosage form
SOLUTION
Route
ORAL
Labeler
Neurocrine Biosciences, Inc.
Application
NDA218820
Marketing category
NDA
Marketing start
2024-12-13
Substance
CRINECERFONT
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CRINECERFONT50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMFT24BX55I
Rxcui2701391, 2701397, 2701399, 2701401, 2701403, 2701405, 2701409, 2701413

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c2799e78-2144-4880-bdd4-e462bf86e355Product name120250805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70370-5250-1Crenessity30 mL in 1 BOTTLESOLUTION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70370-5250-1ML - Milliliter70370-5250a81d878a-d618-4ebc-84ca-d33d9c98ea5d12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70370-5250CRENESSITY (CRINECERFONT) CAPSULE CRENESSITY (CRINECERFONT) SOLUTION [NEUROCRINE BIOSCIENCES, INC.]5Current NDC, 1 package rows20250213_fd3a6fbd-9137-428a-ba46-df6606f07d28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2701397Crenessity 100 MG Oral CapsulePSNfd3a6fbd-9137-428a-ba46-df6606f07d285
2701401Crenessity 25 MG Oral CapsulePSNfd3a6fbd-9137-428a-ba46-df6606f07d285
2701405Crenessity 50 MG Oral CapsulePSNfd3a6fbd-9137-428a-ba46-df6606f07d285
2701413Crenessity 50 MG/mL Oral SolutionPSNfd3a6fbd-9137-428a-ba46-df6606f07d285
2701391crinecerfont 100 MG Oral CapsulePSNfd3a6fbd-9137-428a-ba46-df6606f07d285
2701399crinecerfont 25 MG Oral CapsulePSNfd3a6fbd-9137-428a-ba46-df6606f07d285
2701403crinecerfont 50 MG Oral CapsulePSNfd3a6fbd-9137-428a-ba46-df6606f07d285
2701409crinecerfont 50 MG/mL Oral SolutionPSNfd3a6fbd-9137-428a-ba46-df6606f07d285
2701397crinecerfont 100 MG Oral Capsule [Crenessity]SBDfd3a6fbd-9137-428a-ba46-df6606f07d285
2701401crinecerfont 25 MG Oral Capsule [Crenessity]SBDfd3a6fbd-9137-428a-ba46-df6606f07d285
2701405crinecerfont 50 MG Oral Capsule [Crenessity]SBDfd3a6fbd-9137-428a-ba46-df6606f07d285
2701413crinecerfont 50 MG/ML Oral Solution [Crenessity]SBDfd3a6fbd-9137-428a-ba46-df6606f07d285
2701391crinecerfont 100 MG Oral CapsuleSCDfd3a6fbd-9137-428a-ba46-df6606f07d285
2701399crinecerfont 25 MG Oral CapsuleSCDfd3a6fbd-9137-428a-ba46-df6606f07d285
2701403crinecerfont 50 MG Oral CapsuleSCDfd3a6fbd-9137-428a-ba46-df6606f07d285
2701409crinecerfont 50 MG/ML Oral SolutionSCDfd3a6fbd-9137-428a-ba46-df6606f07d285
2701397Crenessity 100 MG Oral CapsuleSYfd3a6fbd-9137-428a-ba46-df6606f07d285
2701401Crenessity 25 MG Oral CapsuleSYfd3a6fbd-9137-428a-ba46-df6606f07d285
2701405Crenessity 50 MG Oral CapsuleSYfd3a6fbd-9137-428a-ba46-df6606f07d285
2701413Crenessity 50 MG/ML Oral SolutionSYfd3a6fbd-9137-428a-ba46-df6606f07d285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70370-5250-17037052500130 mL in 1 BOTTLE (70370-5250-1) 30 ml2024-12-13NoNoHistorical