Colistimethate

Product NDC: 45932-0023
11-digit product format: 459320023
Labeler code: 45932
Product ID: 45932-0023_55c6e7db-dff7-4a3b-9cb1-78255cae8b09
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colistimethate sodium
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Xellia Pharmaceuticals ApS
Application: ANDA205356
Marketing category: ANDA
Marketing start: 2012-11-22
Marketing end: 0000-00-00
Substance: COLISTIMETHATE
Active strength: 150 mg/2mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	45932-0023		D	Discontinued by firm	2026-08-17
excluded package	package	45932-0023	45932-0023-1	D	Discontinued by firm	2026-08-17
excluded package	package	45932-0023	45932-0023-2	D	Discontinued by firm	2026-08-17
excluded package	package	45932-0023	45932-0023-3	D	Discontinued by firm	2026-08-17
excluded package	package	45932-0023	45932-0023-4	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 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45932-0023-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45932-0023-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45932-0023-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45932-0023-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45932-0023-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45932-0023-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45932-0023-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45932-0023-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45932-0023-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45932-0023-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45932-0023-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45932-0023-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45932-0023-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45932-0023-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45932-0023-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45932-0023-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45932-0023-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45932-0023-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45932-0023-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45932-0023-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45932-0023-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45932-0023-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45932-0023-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45932-0023-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45932-0023-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45932-0023-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45932-0023-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45932-0023-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45932-0023-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45932-0023-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45932-0023-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45932-0023-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45932-0023-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45932-0023-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45932-0023-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45932-0023-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45932-0023-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45932-0023-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45932-0023-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45932-0023-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45932-0023-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45932-0023-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45932-0023-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45932-0023-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45932-0023-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45932-0023-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45932-0023-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45932-0023-3	`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
A205356-001	COLISTIMETHATE SODIUM	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2015-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205356-001	AP

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2015-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205356-001	COLISTIMETHATE SODIUM	EQ 150MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-05-29	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A205356-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205356-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205356-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205356-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205356-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205356-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205356-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205356-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205356-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205356-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205356-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205356-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205356-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205356-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205356-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205356-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205356-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205356-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205356-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205356-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205356-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205356-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205356-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205356-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205356-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205356-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205356-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205356-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205356-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205356-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205356-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205356-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205356-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205356-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205356-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205356-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205356-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205356-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205356-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205356-001	AP	1	`e64feba35796…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
colistimethate	ACTIVE INGREDIENT	DL2R53P963	COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION [XELLIA PHARMACEUTICALS APS]	4
colistin	ACTIVE MOIETY	Z67X93HJG1	COLISTIMETHATE (COLISTIMETHATE SODIUM) INJECTION [XELLIA PHARMACEUTICALS APS]	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colistimethate	COLISTIMETHATE SODIUM	Xellia Pharmaceuticals USA LLC	8ec7dc90-825c-422e-9f4b-c8ace9d93af5	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205356 application number: ANDA205356
Colistimethate	COLISTIMETHATE SODIUM	Hikma Pharmaceuticals USA Inc.	bf556f89-6373-45cb-b465-d991fde7eab9	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205356 application number: ANDA205356
Colistimethate	COLISTIMETHATE SODIUM	Xellia Pharmaceuticals USA LLC	13dc3525-1879-4bd8-a922-81bc1397d5af	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205356 application number: ANDA205356

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45932-0023-1	45932002301	1 VIAL in 1 CARTON (45932-0023-1) > 2 mL in 1 VIAL	1 vial	2012-11-22	0000-00-00	No	No	Current
45932-0023-2	45932002302	6 VIAL in 1 CARTON (45932-0023-2) > 2 mL in 1 VIAL	6 vial	2012-11-22	0000-00-00	No	No	Current
45932-0023-3	45932002303	10 VIAL in 1 CARTON (45932-0023-3) > 2 mL in 1 VIAL	10 vial	2012-11-22	0000-00-00	No	No	Current
45932-0023-4	45932002304	12 VIAL in 1 CARTON (45932-0023-4) > 2 mL in 1 VIAL	12 vial	2012-11-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colistimethate for Injection, USP	Xellia Pharmaceuticals ApS	2017-07-17	HUMAN PRESCRIPTION DRUG LABEL	6