POLYMYXIN B

Product NDC: 45932-0030
11-digit product format: 459320030
Labeler code: 45932
Product ID: 45932-0030_5039c2fa-cc43-4787-933c-a9943ca381eb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POLYMYXIN B SULFATE
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler: Xellia Pharmaceuticals ApS
Application: ANDA202766
Marketing category: ANDA
Marketing start: 2014-01-24
Marketing end: 0000-00-00
Substance: POLYMYXIN B SULFATE
Active strength: 500000 1/1
Pharmacologic classes: Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45932-0030		I	Inactivated by FDA		2026-08-11
excluded package	package	45932-0030	45932-0030-1	I	Inactivated by FDA		2026-08-11

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 · 42 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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`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	45932-0030-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45932-0030-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45932-0030-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45932-0030-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	45932-0030-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	45932-0030-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	45932-0030-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	45932-0030-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	45932-0030-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	45932-0030-1	`9bebd1f3094a…`	`5416666fcb17…`

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

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
A202766-001	POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202766-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2014-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2014-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2014-01-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2014-01-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2014-01-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2014-01-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2014-01-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2014-01-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202766-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-01-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A202766-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202766-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202766-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202766-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202766-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202766-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202766-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202766-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202766-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202766-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202766-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202766-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202766-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202766-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202766-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202766-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202766-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202766-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202766-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202766-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202766-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202766-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202766-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202766-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202766-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202766-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202766-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202766-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202766-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202766-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202766-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202766-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202766-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202766-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202766-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202766-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202766-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202766-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202766-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202766-001	AP	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45932-0030-1	2020-01-31	C162847	48780-1	9d75b9d0-1ef1-f424-e053-dadaa90a57ce	Rx ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45932-0030-1	POLYMYXIN B	1 in 1 VIAL	INJECTION	1		3
45932-0030-1	POLYMYXIN B	10 in 1 CARTON	INJECTION	10		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45932-0030	POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION [XELLIA PHARMACEUTICALS APS]	3	Legacy NDC, 2 package rows	20160218_132fe072-9c9a-4c56-9004-c27ee6a467ae.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Polymyxin B	POLYMYXIN B SULFATE	Xellia Pharmaceuticals USA LLC	b56f18c0-ef5e-4ed9-a5af-f79f3cd189b6	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202766 application number: ANDA202766
Polymyxin B	POLYMYXIN B SULFATE	Hikma Pharmaceuticals USA Inc.	d2bf65f6-2763-4859-a665-ad5e6cde71ee	2025-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202766 application number: ANDA202766
Polymyxin B	POLYMYXIN B SULFATE	Fresenius Kabi USA, LLC	72dd6de6-31d6-4a8f-881b-91af91ed9314	2022-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202766 application number: ANDA202766

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204509	polymyxin B Variable Concentration Multi-Use Injectable Solution	PSN	132fe072-9c9a-4c56-9004-c27ee6a467ae	3
204509	polymyxin B 250000 UNT/ML Injectable Solution	SCD	132fe072-9c9a-4c56-9004-c27ee6a467ae	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45932-0030-1	45932003001	1 in 1 VIAL	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POLYMYXIN B - Xellia Pharmaceuticals ApS \| Gland Pharma Limited	Xellia Pharmaceuticals ApS \| Gland Pharma Limited	2016-02-16	Human Prescription Drug Label	3