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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205266-001	ODOMZO	SONIDEGIB PHOSPHATE	EQ 200MG BASE	CAPSULE / ORAL		RLD, RS	2015-07-24

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18
N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18
N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205266-001	ODOMZO	EQ 200MG BASE	CAPSULE / ORAL	RLD, RS	2015-07-24	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205266-001	8063043	2029-09-15		Drug substance, Drug product	2015-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205266-001	10266523	2036-03-30		Drug substance, Drug product	2022-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205266-001	8178563	2029-07-24	U-1722	Drug substance	2015-08-18	`301d65b070ca…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205266-001	NCE	2020-07-24	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N205266-001	NCE	2020-07-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205266-001	NCE	2020-07-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205266-001	NCE	2020-07-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205266-001	NCE	2020-07-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205266-001	NCE	2020-07-24	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SONIDEGIB PHOSPHATE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W421AI34UW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
028312dc-d155-4fd5-8abd-6bb9f011d3cc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59ef3b26-8c4c-4f7d-80ae-14880c11a219	Product name	1	20150731

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
47335-303-83	2020-07-31	C162847	48780-1	ab0e2407-30b8-f274-e053-dbdaa90a6471	These 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
47335-303-83	2020-07-22	C162847	48780-1	ab0e2407-30b8-f274-e053-dbdaa90a6471	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
47335-303-15	Odomzo	30 in 1 BOTTLE	CAPSULE	30		14
47335-303-83	Odomzo	30 in 1 BOTTLE	CAPSULE	30		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-303-83	EA - Each	47335-303	8cffe184-ef0d-4d6e-95ad-8e34ee995f09	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-303	ODOMZO (SONIDEGIB) CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20250103_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Odomzo	SONIDEGIB	Sun Pharmaceutical Industries, Inc.	028312dc-d155-4fd5-8abd-6bb9f011d3cc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205266 application number: NDA205266 ndc (product): 47335-303

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W421AI34UW	SONIDEGIB PHOSPHATE	1218778-77-8	SONIDEGIB PHOSPHATE
0RLU3VTK5M	SONIDEGIB	956697-53-3	sonidegib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1659927	Odomzo 200 MG Oral Capsule	PSN	028312dc-d155-4fd5-8abd-6bb9f011d3cc	14
1659921	sonidegib 200 MG Oral Capsule	PSN	028312dc-d155-4fd5-8abd-6bb9f011d3cc	14
1659927	sonidegib 200 MG Oral Capsule [Odomzo]	SBD	028312dc-d155-4fd5-8abd-6bb9f011d3cc	14
1659921	sonidegib 200 MG Oral Capsule	SCD	028312dc-d155-4fd5-8abd-6bb9f011d3cc	14
1659927	Odomzo 200 MG (as sonidegib phosphate) Oral Capsule	SY	028312dc-d155-4fd5-8abd-6bb9f011d3cc	14
1659921	sonidegib 200 MG (as sonidegib phosphate) Oral Capsule	SY	028312dc-d155-4fd5-8abd-6bb9f011d3cc	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-303-15	47335030315	30 CAPSULE in 1 BOTTLE (47335-303-15)	30 capsule	2017-09-21		No	No	Current
47335-303-83	47335030383	30 CAPSULE in 1 BOTTLE (47335-303-83)	30 capsule	2017-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Odomzo	Sun Pharmaceutical Industries, Inc. \| Lonza AG \| Patheon Inc.	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	14