FDA.reportPublic FDA data

Odomzo

Product NDC
47335-303
11-digit product format
473350303
Labeler code
47335
Product ID
47335-303_001dc6f2-7476-4ffd-8ea4-be2f97a2b6b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sonidegib
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA205266
Marketing category
NDA
Marketing start
2017-09-21
Substance
SONIDEGIB PHOSPHATE
Active strength
200 mg/1
Pharmacologic classes
Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SONIDEGIB PHOSPHATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW421AI34UW
Rxcui1659921, 1659927

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59ef3b26-8c4c-4f7d-80ae-14880c11a219Product name120150731

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47335-303-832020-07-31C16284748780-1ab0e2407-30b8-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ODOMZO safely and effectively. See full prescribing information for ODOMZO. ODOMZO ® (sonidegib) capsules, for oral use Initial U.S. Approval: 2015
47335-303-832020-07-22C16284748780-1ab0e2407-30b8-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use ODOMZO safely and effectively. See full prescribing information for ODOMZO. ODOMZO ® (sonidegib) capsules, for oral use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-303-15Odomzo30 in 1 BOTTLECAPSULE3014
47335-303-83Odomzo30 in 1 BOTTLECAPSULE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-303-83EA - Each47335-3038cffe184-ef0d-4d6e-95ad-8e34ee995f0912017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-303ODOMZO (SONIDEGIB) CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]14Current NDC, Legacy NDC, 2 package rows20250103_028312dc-d155-4fd5-8abd-6bb9f011d3cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659927Odomzo 200 MG Oral CapsulePSN028312dc-d155-4fd5-8abd-6bb9f011d3cc14
1659921sonidegib 200 MG Oral CapsulePSN028312dc-d155-4fd5-8abd-6bb9f011d3cc14
1659927sonidegib 200 MG Oral Capsule [Odomzo]SBD028312dc-d155-4fd5-8abd-6bb9f011d3cc14
1659921sonidegib 200 MG Oral CapsuleSCD028312dc-d155-4fd5-8abd-6bb9f011d3cc14
1659927Odomzo 200 MG (as sonidegib phosphate) Oral CapsuleSY028312dc-d155-4fd5-8abd-6bb9f011d3cc14
1659921sonidegib 200 MG (as sonidegib phosphate) Oral CapsuleSY028312dc-d155-4fd5-8abd-6bb9f011d3cc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-303-154733503031530 CAPSULE in 1 BOTTLE (47335-303-15) 30 capsule2017-09-21NoNoCurrent
47335-303-834733503038330 CAPSULE in 1 BOTTLE (47335-303-83) 30 capsule2017-09-210000-00-00NoNoCurrent