Protriptyline Hydrochloride

Product NDC: 42806-096
11-digit product format: 428060096
Labeler code: 42806
Product ID: 42806-096_e68d74c7-1d6a-4453-bb46-0047047b7527
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Protriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Epic Pharma, LLC
Application: ANDA202220
Marketing category: ANDA
Marketing start: 2013-01-09
Substance: PROTRIPTYLINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202220-001	PROTRIPTYLINE HYDROCHLORIDE	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19
A202220-002	PROTRIPTYLINE HYDROCHLORIDE	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2012-11-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202220-001	AB
A202220-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2012-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2012-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2012-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2012-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202220-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-11-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202220-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2012-11-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202220-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202220-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202220-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202220-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202220-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202220-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202220-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202220-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202220-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202220-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202220-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202220-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202220-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202220-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202220-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202220-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202220-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202220-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202220-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202220-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202220-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202220-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202220-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202220-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202220-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202220-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202220-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202220-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202220-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202220-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202220-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202220-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202220-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202220-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202220-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202220-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202220-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202220-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202220-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202220-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Protriptyline Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROTRIPTYLINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
44665V00O8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905168	Internal RxNorm lookup
905172	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
c6c7c39e-e510-4f4a-bf7a-926f0e075d3a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
827db2a4-2747-4bc2-b3aa-fde23307b13c	Product name	2	20201013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42806-096-01	Protriptyline Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	10
42806-096-10	Protriptyline Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	10
42806-096-30	Protriptyline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42806-096-01	EA - Each	42806-096	2554f531-000a-47a3-af5b-3e11bead2185	1	2013-03-03
42806-096-30	EA - Each	42806-096	7bed87ae-0764-4785-bb28-5369987705ce	1	2020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROTRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	44665V00O8	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
PROTRIPTYLINE	ACTIVE MOIETY	4NDU154T12	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
STARCH, POTATO	INACTIVE INGREDIENT	8I089SAH3T	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
STARCH, TAPIOCA	INACTIVE INGREDIENT	24SC3U704I	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-096	PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC]	10	Current NDC, Legacy NDC, 3 package rows	20231221_c6c7c39e-e510-4f4a-bf7a-926f0e075d3a.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
Protriptyline Hydrochloride	PROTRIPTYLINE HYDROCHLORIDE	Epic Pharma, LLC	c6c7c39e-e510-4f4a-bf7a-926f0e075d3a	2023-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202220 application number: ANDA202220 ndc (product): 42806-096

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44665V00O8	PROTRIPTYLINE HYDROCHLORIDE	1225-55-4	PROTRIPTYLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905168	protriptyline HCl 10 MG Oral Tablet	PSN	c6c7c39e-e510-4f4a-bf7a-926f0e075d3a	10
905172	protriptyline HCl 5 MG Oral Tablet	PSN	c6c7c39e-e510-4f4a-bf7a-926f0e075d3a	10
905168	protriptyline hydrochloride 10 MG Oral Tablet	SCD	c6c7c39e-e510-4f4a-bf7a-926f0e075d3a	10
905172	protriptyline hydrochloride 5 MG Oral Tablet	SCD	c6c7c39e-e510-4f4a-bf7a-926f0e075d3a	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42806-096-01	42806009601	100 TABLET, FILM COATED in 1 BOTTLE (42806-096-01)	2013-01-09	0000-00-00	No	No	Current
42806-096-10	42806009610	1000 TABLET, FILM COATED in 1 BOTTLE (42806-096-10)	2013-01-09	0000-00-00	No	No	Current
42806-096-30	42806009630	30 TABLET, FILM COATED in 1 BOTTLE (42806-096-30)	2020-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Protriptyline Hydrochloride Tablets, USP Rx Only	Epic Pharma, LLC	2023-07-25	HUMAN PRESCRIPTION DRUG LABEL	10