Coly-Mycin

Product NDC: 42023-107
11-digit product format: 420230107
Labeler code: 42023
Product ID: 42023-107_c8e9dd7e-ffbc-4d56-bdb7-fd41951bcee6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colistimethate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Endo USA, Inc.
Application: NDA050108
Marketing category: NDA
Marketing start: 2007-11-01
Marketing end: 2027-05-31
Substance: COLISTIMETHATE SODIUM
Active strength: 150 mg/2mL
Pharmacologic classes: Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	42023-107	42023-107-06	D	Discontinued by firm		2026-08-17

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 · 12 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…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050108-002	COLY-MYCIN M	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION		RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050108-002	COLY-MYCIN M	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050108-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050108-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050108-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050108-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050108-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050108-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050108-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050108-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050108-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050108-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050108-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050108-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050108-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050108-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050108-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050108-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050108-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050108-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050108-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050108-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050108-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050108-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050108-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050108-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050108-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050108-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050108-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050108-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050108-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050108-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050108-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050108-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050108-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050108-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050108-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050108-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050108-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050108-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050108-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050108-002	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Coly-Mycin
Brand name suffix: M

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COLISTIMETHATE SODIUM	150 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XW0E5YS77G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1117522	Internal RxNorm lookup
1117525	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
6d6e13e2-dc33-4b7b-84d0-66146a57c552	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f304a07f-cb4d-4a13-bc6d-a0095b865f96	Product name	1	20150611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42023-107-01	Coly-MycinM	1 in 1 CARTON	INJECTION	1	26
42023-107-01	Coly-MycinM	2 mL in 1 VIAL	INJECTION	2	26
42023-107-06	Coly-MycinM	6 in 1 CARTON	INJECTION	6	26
42023-107-06	Coly-MycinM	2 mL in 1 VIAL	INJECTION	2	26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-107-01	EA - Each	42023-107	559528bf-b4cb-4785-9b2b-ebebaf8ab0d0	1	2012-07-24
42023-107-06	EA - Each	42023-107	b4d33599-88fc-4774-a246-63f724c68702	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
colistimethate sodium	ACTIVE INGREDIENT	XW0E5YS77G	COLY-MYCIN M (COLISTIMETHATE) INJECTION [JHP PHARMACEUTICALS LLC]	8
colistimethate	ACTIVE MOIETY	DL2R53P963	COLY-MYCIN M (COLISTIMETHATE) INJECTION [JHP PHARMACEUTICALS LLC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-107	COLY-MYCIN M (COLISTIMETHATE) INJECTION [ENDO USA, INC.]	22	Current NDC, Legacy NDC, 4 package rows	20241114_6d6e13e2-dc33-4b7b-84d0-66146a57c552.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
Coly-Mycin M	COLISTIMETHATE	Par Health USA, LLC	6d6e13e2-dc33-4b7b-84d0-66146a57c552	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050108 application number: NDA050108 ndc (product): 42023-107

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XW0E5YS77G	COLISTIMETHATE SODIUM	8068-28-8	COLISTIMETHATE SODIUM
DL2R53P963	COLISTIMETHATE	12705-41-8	colistimethate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1117522	colistin 75 MG/ML Injectable Solution	PSN	6d6e13e2-dc33-4b7b-84d0-66146a57c552	26
1117525	Coly-Mycin M 75 MG/ML Injectable Solution	PSN	6d6e13e2-dc33-4b7b-84d0-66146a57c552	26
1117525	colistin 75 MG/ML Injectable Solution [Coly Mycin M]	SBD	6d6e13e2-dc33-4b7b-84d0-66146a57c552	26
1117522	colistin 75 MG/ML Injectable Solution	SCD	6d6e13e2-dc33-4b7b-84d0-66146a57c552	26
1117522	colistin (as colistimethate sodium) 75 MG/ML Injectable Solution	SY	6d6e13e2-dc33-4b7b-84d0-66146a57c552	26
1117525	Coly Mycin M 150 MG per 2 ML Injectable Solution	SY	6d6e13e2-dc33-4b7b-84d0-66146a57c552	26
1117525	Coly-Mycin M 75 MG/ML Injectable Solution	SY	6d6e13e2-dc33-4b7b-84d0-66146a57c552	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-107-01	42023010701	1 VIAL in 1 CARTON (42023-107-01) / 2 mL in 1 VIAL	1 vial	2007-11-01	0000-00-00	No	No	Current
42023-107-06	42023010706	6 VIAL in 1 CARTON (42023-107-06) > 2 mL in 1 VIAL	6 vial	2007-11-01	2022-10-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Coly-Mycin ® M Parenteral (Colistimethate for Injection, USP)	Par Health USA, LLC	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	27