Ketoconazole

Product NDC: 0093-3219
11-digit product format: 000933219
Labeler code: 0093
Product ID: 0093-3219_3027539e-261c-4ac2-a25d-c41fcce3da0f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: CREAM
Route: TOPICAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075581
Marketing category: ANDA
Marketing start: 2019-02-08
Substance: KETOCONAZOLE
Active strength: 20 mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075581-001	KETOCONAZOLE	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2000-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075581-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2000-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2000-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075581-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2000-04-25	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075581-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075581-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075581-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075581-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075581-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075581-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075581-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075581-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075581-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075581-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075581-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075581-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075581-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075581-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075581-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075581-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075581-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075581-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075581-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075581-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075581-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075581-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075581-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075581-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075581-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075581-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075581-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075581-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075581-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075581-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075581-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075581-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075581-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075581-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075581-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075581-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075581-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075581-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075581-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075581-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
KETOCONAZOLE	20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R9400W927I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
203088	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
7fc47a6a-3714-4598-ae3b-d5a229262c21	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5	Product name	2	20250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2	Product name	2	20211209
8bc3781f-20ed-678b-44a7-a981e693c65f	Product name	2	20211209
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ff3a8c91-648c-300b-467e-10703f514265	Product name	2	20180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0093-3219-15	Ketoconazole	15 g in 1 TUBE	CREAM	15	6
0093-3219-15	Ketoconazole	1 in 1 CARTON	CREAM	1	6
0093-3219-30	Ketoconazole	1 in 1 CARTON	CREAM	1	6
0093-3219-30	Ketoconazole	30 g in 1 TUBE	CREAM	30	6
0093-3219-92	Ketoconazole	60 g in 1 TUBE	CREAM	60	6
0093-3219-92	Ketoconazole	1 in 1 CARTON	CREAM	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-3219-15	GM - Gram	0093-3219	7182dbbf-694d-49fe-b1e2-caf7cc1e6a38	1	2019-03-12
0093-3219-30	GM - Gram	0093-3219	11603225-246c-46b8-a574-96fe68d76b4f	1	2019-03-12
0093-3219-92	GM - Gram	0093-3219	e34c3e05-8df4-4a59-952e-bcd2caac4739	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-3219	KETOCONAZOLE CREAM [TEVA PHARMACEUTICALS USA, INC.]	6	Current NDC, Legacy NDC, 6 package rows	20210903_7fc47a6a-3714-4598-ae3b-d5a229262c21.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	02a348b0-1325-4298-8813-83970da32c7a	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075581 application number: ANDA075581
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	dc635682-170d-46ad-a9ba-6a75c6e0950e	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075581 application number: ANDA075581
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	b3b99c8b-4512-4972-935d-602d4b8325c4	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075581 application number: ANDA075581
Ketoconazole	KETOCONAZOLE	Teva Pharmaceuticals USA, Inc.	7fc47a6a-3714-4598-ae3b-d5a229262c21	2021-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075581 application number: ANDA075581 ndc (product): 0093-3219

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R9400W927I	KETOCONAZOLE	65277-42-1	KETOCONAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
203088	ketoconazole 2 % Topical Cream	PSN	02a348b0-1325-4298-8813-83970da32c7a	102
203088	ketoconazole 2 % Topical Cream	PSN	dc635682-170d-46ad-a9ba-6a75c6e0950e	102
203088	ketoconazole 20 MG/ML Topical Cream	SCD	02a348b0-1325-4298-8813-83970da32c7a	102
203088	ketoconazole 20 MG/ML Topical Cream	SCD	dc635682-170d-46ad-a9ba-6a75c6e0950e	102
203088	ketoconazole 2 % Topical Cream	SY	02a348b0-1325-4298-8813-83970da32c7a	102
203088	ketoconazole 2 % Topical Cream	SY	dc635682-170d-46ad-a9ba-6a75c6e0950e	102
203088	ketoconazole 2 % Topical Cream	PSN	7fc47a6a-3714-4598-ae3b-d5a229262c21	6
203088	ketoconazole 20 MG/ML Topical Cream	SCD	7fc47a6a-3714-4598-ae3b-d5a229262c21	6
203088	ketoconazole 2 % Topical Cream	SY	7fc47a6a-3714-4598-ae3b-d5a229262c21	6
203088	ketoconazole 2 % Topical Cream	PSN	b3b99c8b-4512-4972-935d-602d4b8325c4	5
203088	ketoconazole 20 MG/ML Topical Cream	SCD	b3b99c8b-4512-4972-935d-602d4b8325c4	5
203088	ketoconazole 2 % Topical Cream	SY	b3b99c8b-4512-4972-935d-602d4b8325c4	5
203088	ketoconazole 2 % Topical Cream	PSN	b5e3da2b-940d-eac1-e053-2995a90a6058	2
203088	ketoconazole 2 % Topical Cream	PSN	507ee48f-4143-4dee-aac0-14ea1728025d	2
203088	ketoconazole 20 MG/ML Topical Cream	SCD	507ee48f-4143-4dee-aac0-14ea1728025d	2
203088	ketoconazole 20 MG/ML Topical Cream	SCD	b5e3da2b-940d-eac1-e053-2995a90a6058	2
203088	ketoconazole 2 % Topical Cream	SY	507ee48f-4143-4dee-aac0-14ea1728025d	2
203088	ketoconazole 2 % Topical Cream	SY	b5e3da2b-940d-eac1-e053-2995a90a6058	2
203088	ketoconazole 2 % Topical Cream	PSN	1e1de2df-e200-87dc-e063-6294a90a9dbc	1
203088	ketoconazole 20 MG/ML Topical Cream	SCD	1e1de2df-e200-87dc-e063-6294a90a9dbc	1
203088	ketoconazole 2 % Topical Cream	SY	1e1de2df-e200-87dc-e063-6294a90a9dbc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-3219-15	00093321915	1 TUBE in 1 CARTON (0093-3219-15) / 15 g in 1 TUBE	1 tube	2019-02-08	0000-00-00	No	No	Current
0093-3219-30	00093321930	1 TUBE in 1 CARTON (0093-3219-30) / 30 g in 1 TUBE	1 tube	2019-02-08	0000-00-00	No	No	Current
0093-3219-92	00093321992	1 TUBE in 1 CARTON (0093-3219-92) / 60 g in 1 TUBE	1 tube	2019-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ketoconazole Cream Rx only	RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Ketoconazole Cream Rx only	Preferred Pharmaceuticals, Inc.	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	5
Ketoconazole Cream Rx only	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	102
Ketoconazole Cream Rx only	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	102
Ketoconazole Cream Rx only	REMEDYREPACK INC.	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	4
Ketoconazole Cream Rx only	A-S Medication Solutions	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	5
Ketoconazole Cream Rx only	RPK Pharmaceuticals, Inc.	2023-06-06	HUMAN PRESCRIPTION DRUG LABEL	2
KETOCONAZOLE CREAM Rx only	NuCare Pharmaceuticals,Inc.	2022-01-14	HUMAN PRESCRIPTION DRUG LABEL	2
Ketoconazole Cream Rx only	Teva Pharmaceuticals USA, Inc.	2021-09-02	HUMAN PRESCRIPTION DRUG LABEL	6