SILDENAFIL CITRATE

Product NDC: 60290-079
Requested package NDC: 60290-079-01
11-digit product format: 602900079
Labeler code: 60290
Product ID: 60290-079_51b76a30-43fd-eaa4-e063-6394a90a286d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SILDENAFIL CITRATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Umedica Laboratories USA Inc.
Application: ANDA209302
Marketing category: ANDA
Marketing start: 2026-02-15
Substance: SILDENAFIL CITRATE
Active strength: 25 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209302-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25
A209302-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25
A209302-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209302-001	AB
A209302-002	AB
A209302-003	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 3 · 107 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
2026-02-19 14:30 UTC	2026-02	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 107 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	A209302-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209302-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-003	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-003	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-003	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-003	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209302-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209302-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILDENAFIL CITRATE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BW9B0ZE037	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312950	Internal RxNorm lookup
314228	Internal RxNorm lookup
314229	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
90477a51-63ba-43f4-a74b-4659a946093c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fabccea2-36c8-9268-ee44-ec231455538f	Product name	9	20241217
ac996ae9-22a2-41c2-bb86-913c4aef95ad	Product name	1	20230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fc	Product name	9	20220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60290-079-01	SILDENAFIL CITRATE	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
60290-079-02	SILDENAFIL CITRATE	90 in 1 BOTTLE	TABLET, FILM COATED	90	4
60290-079-03	SILDENAFIL CITRATE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	4
60290-079-04	SILDENAFIL CITRATE	500 in 1 BOTTLE	TABLET, FILM COATED	500	4

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	f1122baa-8dee-43fc-bd3d-501a55b696b3	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Umedica Laboratories USA Inc.	90477a51-63ba-43f4-a74b-4659a946093c	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302 ndc (package): 60290-079-01 ndc (product): 60290-079 ndc11 (package): 60290007901
SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	5ac95dd0-57e4-495c-bf8d-b2e5bbe33e20	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Northstar Rx LLC	8127ff38-2761-49ec-8ce7-7f971f521cfb	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	8780c159-8b61-402b-afbe-64f5c85d3886	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	30ce6e7f-716e-4a68-a4fb-2bb2d34ed052	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	1add0cab-8873-4cd1-ab53-e05c4ac458b1	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Advanced Rx of Tennessee, LLC	30cb7d6a-ce40-c794-e063-6294a90a6861	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Preferred Pharmaceuticals Inc.	5846bff2-6a93-46a7-a547-04459c590814	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	6d79946b-72a9-4d1b-a84b-9d1a679a82e2	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	59b623bc-fbdd-4f32-8327-0d600763f429	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BW9B0ZE037	SILDENAFIL CITRATE	171599-83-0	SILDENAFIL CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314229	sildenafil citrate 100 MG Oral Tablet	PSN	90477a51-63ba-43f4-a74b-4659a946093c	4
314228	sildenafil citrate 25 MG Oral Tablet	PSN	90477a51-63ba-43f4-a74b-4659a946093c	4
312950	sildenafil citrate 50 MG Oral Tablet	PSN	90477a51-63ba-43f4-a74b-4659a946093c	4
314229	sildenafil 100 MG Oral Tablet	SCD	90477a51-63ba-43f4-a74b-4659a946093c	4
314228	sildenafil 25 MG Oral Tablet	SCD	90477a51-63ba-43f4-a74b-4659a946093c	4
312950	sildenafil 50 MG Oral Tablet	SCD	90477a51-63ba-43f4-a74b-4659a946093c	4
314229	sildenafil 100 MG (as sildenafil citrate) Oral Tablet	SY	90477a51-63ba-43f4-a74b-4659a946093c	4
314228	sildenafil 25 MG (as sildenafil citrate) Oral Tablet	SY	90477a51-63ba-43f4-a74b-4659a946093c	4
312950	sildenafil 50 MG (as sildenafil citrate) Oral Tablet	SY	90477a51-63ba-43f4-a74b-4659a946093c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60290-079-01	60290007901	30 TABLET, FILM COATED in 1 BOTTLE (60290-079-01)	2026-02-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SILDENAFIL CITRATE	Umedica Laboratories USA Inc. \| UMEDICA LABORATORIES PRIVATE LIMITED	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	4