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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205266-001ODOMZOSONIDEGIB PHOSPHATEEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N205266-00181785632029-07-24U-1722Drug substance2015-08-18
N205266-00180630432029-09-15Drug substance, Drug product2015-08-18
N205266-001102665232036-03-30Drug substance, Drug product2022-05-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-243f01610625f2…
2019-09-15 20:21 UTC2019-09N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N205266-001ODOMZOEQ 200MG BASECAPSULE / ORALRLD, RS2015-07-24cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N205266-00181785632029-07-24U-1722Drug substance2015-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205266-00180630432029-09-15Drug substance, Drug product2015-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205266-001102665232036-03-30Drug substance, Drug product2022-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205266-00181785632029-07-24U-1722Drug substance2015-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205266-00180630432029-09-15Drug substance, Drug product2015-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205266-001102665232036-03-30Drug substance, Drug product2022-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N205266-00181785632029-07-24U-1722Drug substance2015-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205266-00180630432029-09-15Drug substance, Drug product2015-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205266-001102665232036-03-30Drug substance, Drug product2022-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205266-00181785632029-07-24U-1722Drug substance2015-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205266-00180630432029-09-15Drug substance, Drug product2015-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205266-001102665232036-03-30Drug substance, Drug product2022-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205266-00181785632029-07-24U-1722Drug substance2015-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205266-00180630432029-09-15Drug substance, Drug product2015-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205266-001102665232036-03-30Drug substance, Drug product2022-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205266-00181785632029-07-24U-1722Drug substance2015-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205266-00180630432029-09-15Drug substance, Drug product2015-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205266-001102665232036-03-30Drug substance, Drug product2022-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205266-00181785632029-07-24U-1722Drug substance2015-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205266-00180630432029-09-15Drug substance, Drug product2015-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205266-001102665232036-03-30Drug substance, Drug product2022-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205266-00181785632029-07-24U-1722Drug substance2015-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205266-00180630432029-09-15Drug substance, Drug product2015-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205266-001102665232036-03-30Drug substance, Drug product2022-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205266-00181785632029-07-24U-1722Drug substance2015-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205266-00180630432029-09-15Drug substance, Drug product2015-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205266-001102665232036-03-30Drug substance, Drug product2022-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205266-00181785632029-07-24U-1722Drug substance2015-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N205266-00180630432029-09-15Drug substance, Drug product2015-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N205266-001102665232036-03-30Drug substance, Drug product2022-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205266-00181785632029-07-24U-1722Drug substance2015-08-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205266-00180630432029-09-15Drug substance, Drug product2015-08-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205266-001102665232036-03-30Drug substance, Drug product2022-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205266-00181785632029-07-24U-1722Drug substance2015-08-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205266-00180630432029-09-15Drug substance, Drug product2015-08-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205266-001102665232036-03-30Drug substance, Drug product2022-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205266-00181785632029-07-24U-1722Drug substance2015-08-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205266-00180630432029-09-15Drug substance, Drug product2015-08-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205266-001102665232036-03-30Drug substance, Drug product2022-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205266-00181785632029-07-24U-1722Drug substance2015-08-188072bd15b7f6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N205266-001NCE2020-07-2474a2ff9319b5…
2020-12-22 03:56 UTC2020-12N205266-001NCE2020-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205266-001NCE2020-07-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205266-001NCE2020-07-243f01610625f2…
2019-09-15 20:21 UTC2019-09N205266-001NCE2020-07-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N205266-001NCE2020-07-24ea99ee380514…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W421AI34UWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659921Internal RxNorm lookup
1659927Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
028312dc-d155-4fd5-8abd-6bb9f011d3ccAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OdomzoSONIDEGIBSun Pharmaceutical Industries, Inc.028312dc-d155-4fd5-8abd-6bb9f011d3cc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 205266
application number: NDA205266
ndc (product): 47335-303

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