BusPIRone Hydrochloride

Product NDC: 53002-5017
Requested package NDC: 53002-5017-6
11-digit product format: 530025017
Labeler code: 53002
Product ID: 53002-5017_d240572e-ddfc-4f9b-9b1b-aade3a013b15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BusPIRone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA209696
Marketing category: ANDA
Marketing start: 2018-07-03
Marketing end: 0000-00-00
Substance: BUSPIRONE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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	53002-5017	53002-5017-6	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209696-001	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03
A209696-002	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03
A209696-003	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03
A209696-004	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03
A209696-005	BUSPIRONE HYDROCHLORIDE	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A209696-001	BX
A209696-002	BX
A209696-003	BX
A209696-004	BX
A209696-005	BX

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 6 · 205 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	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	BX	2018-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-001	BUSPIRONE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-002	BUSPIRONE HYDROCHLORIDE	7.5MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-003	BUSPIRONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-004	BUSPIRONE HYDROCHLORIDE	15MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-005	BUSPIRONE HYDROCHLORIDE	30MG	TABLET / ORAL	AB	2018-05-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A209696-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-003	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-004	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209696-005	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-003	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-004	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209696-005	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209696-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-004	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209696-005	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209696-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209696-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209696-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209696-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209696-005	AB	1	`5bbf6a4d5a75…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-5017-0	2023-01-30	C162847	48780-1	f386c649-ddf2-0266-e053-dadaa90a7c1a	Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) Rx Only
53002-5017-3	2023-01-30	C162847	48780-1	f386c649-ddf2-0266-e053-dadaa90a7c1a	Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) Rx Only
53002-5017-6	2023-01-30	C162847	48780-1	f386c649-ddf2-0266-e053-dadaa90a7c1a	Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-5017-0	BusPIRone Hydrochloride	100 in 1 BOTTLE	TABLET	100	1
53002-5017-3	BusPIRone Hydrochloride	30 in 1 BOTTLE	TABLET	30	1
53002-5017-6	BusPIRone Hydrochloride	60 in 1 BOTTLE	TABLET	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-5017	BUSPIRONE HYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 3 package rows	20201224_e32e6011-4db6-4d85-8c7f-d5c2c2474a6a.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 · 5 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	267d8897-90dd-4f8a-bbd8-8aa4e47c2905	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	APNAR PHARMA LP	3c115eea-9dbc-4e2c-9d79-42e3388fde5a	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696
Buspirone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Nivagen Pharmaceuticals Inc.	b08dd2e7-e808-4b51-b404-5009076b82eb	2021-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696
BusPIRone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Proficient Rx LP	03efd618-8ca3-43d0-bbeb-55e53b5308e8	2020-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696
BusPIRone Hydrochloride	BUSPIRONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e2c672b3-6130-4dd1-8066-0ce9451cb8c7	2019-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209696 application number: ANDA209696

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	e32e6011-4db6-4d85-8c7f-d5c2c2474a6a	1
866083	buspirone hydrochloride 10 MG Oral Tablet	SCD	e32e6011-4db6-4d85-8c7f-d5c2c2474a6a	1
866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY	e32e6011-4db6-4d85-8c7f-d5c2c2474a6a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-5017-6	53002501706	60 TABLET in 1 BOTTLE (53002-5017-6)	60 tablet	2019-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included) Rx Only	RPK Pharmaceuticals, Inc.	2020-12-23	HUMAN PRESCRIPTION DRUG LABEL	1