Trimipramine

Product NDC: 51991-945
Requested package NDC: 51991-945-01
11-digit product format: 519910945
Labeler code: 51991
Product ID: 51991-945_e1cadaf3-e932-4bfb-a8fa-57fb52f7dc67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trimipramine
Dosage form: CAPSULE
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA208127
Marketing category: ANDA
Marketing start: 2017-04-05
Substance: TRIMIPRAMINE MALEATE
Active strength: 50 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	51991-945	51991-945-01	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208127-001	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15
A208127-002	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15
A208127-003	TRIMIPRAMINE MALEATE	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208127-001	AB
A208127-002	AB
A208127-003	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 4 · 123 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	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-002	TRIMIPRAMINE MALEATE	EQ 50MG BASE	CAPSULE / ORAL	AB	RS	2016-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-003	TRIMIPRAMINE MALEATE	EQ 100MG BASE	CAPSULE / ORAL	AB		2016-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208127-001	TRIMIPRAMINE MALEATE	EQ 25MG BASE	CAPSULE / ORAL	AB		2016-04-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A208127-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208127-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208127-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208127-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208127-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208127-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208127-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208127-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208127-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208127-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208127-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208127-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208127-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208127-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208127-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208127-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208127-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Trimipramine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIMIPRAMINE MALEATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
269K6498LD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313496	Internal RxNorm lookup
313498	Internal RxNorm lookup
313499	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
4f31df66-7dc2-1f04-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1c70dfe2-7a86-036d-045f-091057d656a1	Product name	2	20160609

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51991-945-01	Trimipramine	100 in 1 BOTTLE	CAPSULE	100		17
51991-945-33	Trimipramine	30 in 1 BOTTLE	CAPSULE	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-945-01	EA - Each	51991-945	261ceac6-966e-43fc-a62a-77f2e22aea5d	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-945	TRIMIPRAMINE MALEATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20250209_4f31df66-7dc2-1f04-e054-00144ff88e88.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
Trimipramine	TRIMIPRAMINE	Breckenridge Pharmaceutical, Inc.	4f31df66-7dc2-1f04-e054-00144ff88e88	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208127 application number: ANDA208127 ndc (package): 51991-945-01 ndc (product): 51991-945 ndc11 (package): 51991094501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
269K6498LD	TRIMIPRAMINE MALEATE	521-78-8	TRIMIPRAMINE MALEATE
6S082C9NDT	TRIMIPRAMINE	739-71-9	Trimipramine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313496	trimipramine 100 MG Oral Capsule	PSN	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313498	trimipramine 25 MG Oral Capsule	PSN	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313499	trimipramine 50 MG Oral Capsule	PSN	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313496	trimipramine 100 MG Oral Capsule	SCD	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313498	trimipramine 25 MG Oral Capsule	SCD	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313499	trimipramine 50 MG Oral Capsule	SCD	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313496	trimipramine 100 MG (as trimipramine maleate ) Oral Capsule	SY	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313498	trimipramine 25 MG (as trimipramine maleate ) Oral Capsule	SY	4f31df66-7dc2-1f04-e054-00144ff88e88	17
313499	trimipramine 50 MG (as trimipramine maleate ) Oral Capsule	SY	4f31df66-7dc2-1f04-e054-00144ff88e88	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-945-01	51991094501	100 CAPSULE in 1 BOTTLE (51991-945-01)	100 capsule	2017-04-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRIMIPRAMINE CAPSULES	Breckenridge Pharmaceutical, Inc. \| Rivopharm SA \| LabAnalysis Srl \| Lundbeck Pharmaceuticals Italy S.p.A. \| PCL Research&Manufacturing Srl \| PRC Ticinum Lab S.r.l \| Redox Srl	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	17