Trazodone Hydrochloride

Product NDC: 0603-6161
Requested package NDC: 0603-6161-28
11-digit product format: 006036161
Labeler code: 0603
Product ID: 0603-6161_33d705b2-795f-4fb8-96f2-96d48e6de326
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trazodone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Pharmaceutical
Application: ANDA072193
Marketing category: ANDA
Marketing start: 2010-05-30
Marketing end: 2021-06-30
Substance: TRAZODONE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0603-6161	0603-6161-28	D	Discontinued by firm		2026-08-03

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
A072193-001	TRAZODONE HYDROCHLORIDE	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1989-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072193-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-07-13 05:37 UTC	2024-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A072193-001	TRAZODONE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1989-02-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC	2024-07	A072193-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072193-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072193-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072193-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072193-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072193-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072193-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072193-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072193-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072193-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072193-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072193-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072193-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072193-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072193-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072193-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072193-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072193-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072193-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072193-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072193-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072193-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072193-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072193-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072193-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072193-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072193-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072193-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072193-001	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A072193-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
Trazodone Hydrochloride	TRAZODONE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	283c8236-9776-44cb-b7b2-1024689de736	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072193 application number: ANDA072193

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac7a3d9b-58c0-4ffc-a3eb-ed863453525e	Product name	1	20250730
b2f15d64-48ea-ba98-af5c-91f410667b31	Product name	5	20250314
d8e7f61b-4ab5-0dbe-2706-4e11b6079b87	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-6161-02	EA - Each	0603-6161	c8075bd6-6723-4653-b379-404bd49b23d5	1	2012-07-24
0603-6161-04	EA - Each	0603-6161	b1c6e780-183a-4886-9ebb-bdc4172ab990	1	2012-07-24
0603-6161-16	EA - Each	0603-6161	3f659fd0-b1cb-442d-ad34-84f13141a148	1	2012-07-24
0603-6161-20	EA - Each	0603-6161	394ea989-49a2-4e5e-8fb3-2a95c6340bb2	1	2012-07-24
0603-6161-21	EA - Each	0603-6161	100dd3d2-9843-40f5-bdfd-0dbcbfe703d6	1	2012-07-24
0603-6161-28	EA - Each	0603-6161	c8dca3e9-af0e-4042-8609-e078215586fd	1	2012-07-24
0603-6161-32	EA - Each	0603-6161	31ef2a2c-7a09-4de0-b52a-ee4253b2d273	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	14
TRAZODONE HYDROCHLORIDE	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Trazodone Hydrochloride	ACTIVE INGREDIENT	6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
trazodone	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
TRAZODONE	ACTIVE MOIETY	YBK48BXK30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6E8ZO8LRNM	TRAZODONE HYDROCHLORIDE	25332-39-2	TRAZODONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856373	traZODone HCl 100 MG Oral Tablet	PSN	26d30297-fda9-45a4-b94a-a9f401705818	1
856373	traZODone HCl 100 MG Oral Tablet	PSN	4e0ce52d-2639-42a2-a4e4-7854421fa1b6	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	26d30297-fda9-45a4-b94a-a9f401705818	1
856377	traZODone HCl 50 MG Oral Tablet	PSN	4e0ce52d-2639-42a2-a4e4-7854421fa1b6	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	26d30297-fda9-45a4-b94a-a9f401705818	1
856373	trazodone hydrochloride 100 MG Oral Tablet	SCD	4e0ce52d-2639-42a2-a4e4-7854421fa1b6	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	26d30297-fda9-45a4-b94a-a9f401705818	1
856377	trazodone hydrochloride 50 MG Oral Tablet	SCD	4e0ce52d-2639-42a2-a4e4-7854421fa1b6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-6161-28	00603616128	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6161-28)	2010-05-30	2021-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trazodone Hydrochloride	NuCare Pharmaceuticals, Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	Par Pharmaceutical	2019-11-12	HUMAN PRESCRIPTION DRUG LABEL	19
Trazodone Hydrochloride	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	Lake Erie Medical DBA Quality Care Products LLC	2019-08-12	HUMAN PRESCRIPTION DRUG LABEL	2
Trazodone Hydrochloride	REMEDYREPACK INC.	2019-02-15	HUMAN PRESCRIPTION DRUG LABEL	4
Trazodone Hydrochloride	St. Mary's Medical Park Pharmacy	2018-11-21	HUMAN PRESCRIPTION DRUG LABEL	3
Trazodone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2014-05-13	HUMAN PRESCRIPTION DRUG LABEL	1
TRAZODONE HYDROCHLORIDE TABLETS, USP	Contract Pharmacy Services-PA	2010-08-11	HUMAN PRESCRIPTION DRUG LABEL	1