Buspirone Hydrochloride

Product NDC: 82804-104
11-digit product format: 828040104
Labeler code: 82804
Product ID: 82804-104_244dcf47-36e5-488f-9dc2-bad9b30f7437
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Buspirone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA210907
Marketing category: ANDA
Marketing start: 2019-11-14
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 10 mg/1
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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210907-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14
A210907-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14
A210907-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14
A210907-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A210907-001	AB
A210907-002	AB
A210907-003	AB
A210907-004	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 5 · 164 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
2026-09-14 22:38:34	2026-08	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	RS	2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-002	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-003	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-004	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB		2019-11-14	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210907-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210907-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210907-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210907-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210907-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210907-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210907-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210907-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210907-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210907-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210907-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210907-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210907-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210907-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210907-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210907-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210907-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210907-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUSPIRONE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
207LT9J9OC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866083	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
801803eb-be17-4064-8813-7ccf52316cde	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a9968269-ddf2-400e-9170-7376dcf3545a	Product name	1	20251215
2cf3c2e9-d566-c982-009a-188fe4f776b9	Product name	8	20200428
4a9096ce-7b98-89e5-5942-15f48c4f7abf	Product name	5	20190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82804-104-30	Buspirone Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		2
82804-104-60	Buspirone Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-104-30	EA - Each	82804-104	1e0b5ab8-f89f-4d0b-ab3d-2254af41ecbb	1	2024-08-12
82804-104-60	EA - Each	82804-104	ae56ca36-1deb-4d5d-b028-4801dbec02d8	1	2026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-104	BUSPIRONE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1	Current NDC, 2 package rows	20240517_801803eb-be17-4064-8813-7ccf52316cde.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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	20866697-58cd-4639-ae21-2fff486aec81	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fbd7f3fa-11f8-a319-e053-6294a90acae4	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hcl	BUSPIRONE HCL	Direct Rx	da584ae1-4513-6474-e053-2a95a90aac9d	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f8afd9b8-0885-2f0c-e053-6294a90a9c57	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	932422a8-b72c-4dab-b942-2ab092ed6b01	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	38faa7cb-d858-4481-8649-35d228acbd38	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	19afb386-72a5-c97e-e063-6294a90adaea	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	2a25a718-306f-403e-9928-cae30bc52f12	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	a2867dde-e5dd-4cc8-84d0-59240626868a	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	eab53fff-c052-4466-a673-3d68aab98c27	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Bryant Ranch Prepack	5fa0720f-e236-4b8b-a0c0-6f48037c76b3	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	1886b672-4b88-4b49-ae6a-d2ba2f452e44	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	A-S Medication Solutions	bce96786-4d9a-460e-8d92-9908ea2af07a	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	a6bdf140-075e-445e-a62d-633a4b97f3a8	2023-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210907 application number: ANDA210907

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
207LT9J9OC	BUSPIRONE HYDROCHLORIDE	33386-08-2	BUSPIRONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866083	busPIRone HCl 10 MG Oral Tablet	PSN	801803eb-be17-4064-8813-7ccf52316cde	2
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	801803eb-be17-4064-8813-7ccf52316cde	2
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	801803eb-be17-4064-8813-7ccf52316cde	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-104-30	82804010430	30 TABLET in 1 BOTTLE, PLASTIC (82804-104-30)	30 tablet	2024-05-13	No	No	Current
82804-104-60	82804010460	60 TABLET in 1 BOTTLE, PLASTIC (82804-104-60)	60 tablet	2025-08-14	No	No	Current
82804-104-90	82804010490	90 TABLET in 1 BOTTLE, PLASTIC (82804-104-90)	90 tablet	2026-08-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets, USP Rx Only	Proficient Rx LP	2026-08-01	HUMAN PRESCRIPTION DRUG LABEL	3