Lamotrigine Extended Release

Product NDC: 49884-561
Requested package NDC: 49884-561-11
11-digit product format: 498840561
Labeler code: 49884
Product ID: 49884-561_3c26caa3-84f9-442d-b752-9dda35d0bacb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lamotrigine extended release
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA201791
Marketing category: ANDA
Marketing start: 2013-01-18
Marketing end: 0000-00-00
Substance: LAMOTRIGINE
Active strength: 25 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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	49884-561	49884-561-11	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A201791-001	LAMOTRIGINE	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-002	LAMOTRIGINE	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-003	LAMOTRIGINE	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-004	LAMOTRIGINE	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-005	LAMOTRIGINE	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18
A201791-006	LAMOTRIGINE	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	2013-01-18

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 7 · 258 observed 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
2026-09-14 22:38:34	2026-08	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2013-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-005	LAMOTRIGINE	250MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-006	LAMOTRIGINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-001	LAMOTRIGINE	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-002	LAMOTRIGINE	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-003	LAMOTRIGINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-004	LAMOTRIGINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-18	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 240 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	A201791-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201791-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201791-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201791-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201791-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201791-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201791-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201791-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201791-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201791-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201791-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201791-004	AB	1	`2680178bc6a6…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
14a9502b-3d70-0496-a7e1-b16edaa005b8	Product name	5	20250423
16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0	Product name	7	20250401
e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49884-561-01	Lamotrigine Extended Release	100 in 1 BOTTLE	TABLET	100	21
49884-561-05	Lamotrigine Extended Release	500 in 1 BOTTLE	TABLET	500	21
49884-561-11	Lamotrigine Extended Release	30 in 1 BOTTLE	TABLET	30	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-561-11	EA - Each	49884-561	3dcd8ea7-3f91-45a1-beab-f877e7d271f0	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMOTRIGINE	ACTIVE INGREDIENT	U3H27498KS	LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]	7
LAMOTRIGINE	ACTIVE MOIETY	U3H27498KS	LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]	7
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAMOTRIGINE EXTENDED RELEASE TABLET [PAR PHARMACEUTICAL INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-561	LAMOTRIGINE EXTENDED RELEASE TABLET [ENDO USA, INC.]	15	Legacy NDC, 3 package rows	20240913_fb59c76a-9b6f-40ea-ac3a-58c3195c4377.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
Lamotrigine Extended Release	LAMOTRIGINE EXTENDED RELEASE	Par Health USA, LLC	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201791 application number: ANDA201791 ndc (package): 49884-561-11 ndc (product): 49884-561 ndc11 (package): 49884056111

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3H27498KS	LAMOTRIGINE	84057-84-1	LAMOTRIGINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
850087	lamoTRIgine 100 MG 24HR Extended Release Oral Tablet	PSN	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
900156	lamoTRIgine 200 MG 24HR Extended Release Oral Tablet	PSN	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
900164	lamoTRIgine 25 MG 24HR Extended Release Oral Tablet	PSN	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
1146690	lamoTRIgine 250 MG 24HR Extended Release Oral Tablet	PSN	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
1098608	lamoTRIgine 300 MG 24HR Extended Release Oral Tablet	PSN	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
850091	lamoTRIgine 50 MG 24HR Extended Release Oral Tablet	PSN	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
850087	24 HR lamotrigine 100 MG Extended Release Oral Tablet	SCD	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
900156	24 HR lamotrigine 200 MG Extended Release Oral Tablet	SCD	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
900164	24 HR lamotrigine 25 MG Extended Release Oral Tablet	SCD	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
1146690	24 HR lamotrigine 250 MG Extended Release Oral Tablet	SCD	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
1098608	24 HR lamotrigine 300 MG Extended Release Oral Tablet	SCD	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
850091	24 HR lamotrigine 50 MG Extended Release Oral Tablet	SCD	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
850087	lamotrigine 100 MG 24 HR Extended Release Oral Tablet	SY	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
900156	lamotrigine 200 MG 24 HR Extended Release Oral Tablet	SY	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
900164	lamotrigine 25 MG 24 HR Extended Release Oral Tablet	SY	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
1146690	lamotrigine 250 MG 24 HR Extended Release Oral Tablet	SY	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
1098608	lamotrigine 300 MG 24 HR Extended Release Oral Tablet	SY	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21
850091	lamotrigine 50 MG 24 HR Extended Release Oral Tablet	SY	fb59c76a-9b6f-40ea-ac3a-58c3195c4377	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-561-11	49884056111	30 TABLET in 1 BOTTLE (49884-561-11)	30 tablet	2013-01-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lamotrigine Extended Release	Par Health USA, LLC \| Zhejiang Huahai Pharmaceutical Co., Ltd.	2026-03-01	HUMAN PRESCRIPTION DRUG LABEL	21