Polymyxin B

Product NDC: 0143-9461
11-digit product format: 001439461
Labeler code: 0143
Product ID: 0143-9461_d87f8155-092a-4dd0-8325-417a0ed8f167
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Polymyxin B Sulfate
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA202766
Marketing category: ANDA
Marketing start: 2025-09-30
Substance: POLYMYXIN B SULFATE
Active strength: 500000 [USP'U]/1
Pharmacologic classes: Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Polymyxin B
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POLYMYXIN B SULFATE	500000 [USP'U]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19371312D4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204509	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
d2bf65f6-2763-4859-a665-ad5e6cde71ee	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0143-9461-01	Polymyxin B	1 in 1 VIAL, GLASS	INJECTION, POWDER, FOR SOLUTION	1	13
0143-9461-01	Polymyxin B	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1	13
0143-9461-10	Polymyxin B	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	13
0143-9461-10	Polymyxin B	1 in 1 VIAL, GLASS	INJECTION, POWDER, FOR SOLUTION	1	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9461-01	EA - Each	0143-9461	c60732d4-4a7c-4fa5-90a1-f5050a703fca	1	2025-11-13
0143-9461-10	EA - Each	0143-9461	9de5214d-99f8-435a-9c55-c72d9c812359	1	2025-11-13

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 ndc (product): 0143-9461
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	d2bf65f6-2763-4859-a665-ad5e6cde71ee	13
204509	polymyxin B 250000 UNT/ML Injectable Solution	SCD	d2bf65f6-2763-4859-a665-ad5e6cde71ee	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0143-9461-01	00143946101	1 VIAL, GLASS in 1 CARTON (0143-9461-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS	2025-09-30	No	No	Current
0143-9461-10	00143946110	10 VIAL, GLASS in 1 CARTON (0143-9461-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS	2025-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POLYMYXIN B for INJECTION, USP 500,000 Units/vial	Hikma Pharmaceuticals USA Inc. \| Xellia Pharmaceuticals ApS	2025-05-23	HUMAN PRESCRIPTION DRUG LABEL	13