Halobetasol Propionate

Product NDC: 85437-008
11-digit product format: 854370008
Labeler code: 85437
Product ID: 85437-008_4d3f3b6d-7f22-1f5c-e063-6294a90a45b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Halobetasol propionate
Dosage form: LOTION
Route: TOPICAL
Labeler: Coral Way Pharma, LLC
Application: NDA208183
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2026-03-10
Marketing end: 2027-05-31
Substance: HALOBETASOL PROPIONATE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208183-001	ULTRAVATE	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		RLD, RS	2015-11-06

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208183-001	NPP	2023-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208183-001	NPP	2023-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208183-001	NPP	2023-08-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208183-001	NPP	2023-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208183-001	NPP	2023-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208183-001	NPP	2023-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208183-001	NPP	2023-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208183-001	NPP	2023-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208183-001	NPP	2023-08-31	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N208183-001	NPP	2023-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208183-001	NPP	2023-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208183-001	NPP	2023-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208183-001	NPP	2023-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208183-001	NPP	2023-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208183-001	NPP	2023-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208183-001	NPP	2023-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208183-001	NPP	2023-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208183-001	NPP	2023-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208183-001	NPP	2023-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208183-001	NPP	2023-08-31	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Halobetasol Propionate

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HALOBETASOL PROPIONATE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
91A0K1TY3Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1789962	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
4cb1f7b3-c412-6fc7-e063-6394a90a63c9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6	Product name	2	20260220
9314f950-fe47-4276-b1f9-66d9d4a64eae	Product name	1	20220217
0bc08e12-b8ed-4802-abab-926d5509afb3	Product name	1	20210513
608e9379-3a63-4bf4-b035-b393ae8faa97	Product name	1	20190214
83c1408d-b2bb-43b6-84ca-4f3e3e6f11d3	Product name	1	20151123
9badac54-f0c2-d87e-de70-c4ea0b9cf6a2	Product name	1	20140508
ee2f33ab-1561-3107-e994-434cb17b4d06	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85437-008-60	Halobetasol Propionate	59 g in 1 BOTTLE	LOTION	59		4
85437-008-60	Halobetasol Propionate	1 in 1 CARTON	LOTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85437-008-60	ML - Milliliter	85437-008	fa9fa110-e560-4f61-b6ac-49e4c65ef06c	1	2026-04-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halobetasol Propionate	HALOBETASOL PROPIONATE	Coral Way Pharma, LLC	4cb1f7b3-c412-6fc7-e063-6394a90a63c9	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208183 application number: NDA208183 ndc (product): 85437-008
ULTRAVATE	HALOBETASOL PROPIONATE	Lacer Pharma, LLC	74e899db-1c1f-48b2-9913-5d32a14906ae	2025-04-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208183 application number: NDA208183

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
91A0K1TY3Z	HALOBETASOL PROPIONATE	66852-54-8	HALOBETASOL PROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1789962	halobetasol propionate 0.05 % Topical Lotion	PSN	4cb1f7b3-c412-6fc7-e063-6394a90a63c9	4
1789962	halobetasol propionate 0.5 MG/ML Topical Lotion	SCD	4cb1f7b3-c412-6fc7-e063-6394a90a63c9	4
1789962	halobetasol propionate 0.05 % Topical Lotion	SY	4cb1f7b3-c412-6fc7-e063-6394a90a63c9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
85437-008-60	85437000860	1 BOTTLE in 1 CARTON (85437-008-60) / 59 g in 1 BOTTLE	1 bottle	2026-03-10	2027-05-31	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Halobetasol Propionate	Coral Way Pharma, LLC \| Ferndale Laboratories, Inc.	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	5