POLYMYXIN B

Product NDC: 63323-321
11-digit product format: 633230321
Labeler code: 63323
Product ID: 63323-321_545b3d1d-6c8f-44aa-b81e-b24fc99f9c82
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POLYMYXIN B SULFATE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Labeler: Fresenius Kabi USA, LLC
Application: ANDA065372
Marketing category: ANDA
Marketing start: 2009-11-17
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: 2026-12-31
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
A065372-001	POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2008-01-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065372-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065372-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	2008-01-10	`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	A065372-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065372-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065372-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065372-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065372-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065372-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065372-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065372-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065372-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065372-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065372-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065372-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065372-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065372-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065372-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065372-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065372-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065372-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065372-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065372-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065372-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065372-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065372-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065372-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065372-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065372-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065372-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065372-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065372-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065372-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065372-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065372-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065372-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065372-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065372-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065372-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065372-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065372-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065372-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065372-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: POLYMYXIN B
Listing expiration: 2026-12-31

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
fbc12c18-567b-41bc-89d0-efd29616615c	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
63323-321-01	POLYMYXIN B	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1	4
63323-321-10	POLYMYXIN B	10 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	10	4
63323-321-02	POLYMYXIN B	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1	1
63323-321-12	POLYMYXIN B	10 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-321-01	EA - Each	63323-321	be16a189-5df5-47a8-b45a-cdb1b65a94c3	1	2021-12-08
63323-321-02	EA - Each	63323-321	bfda5fd4-1a9f-4670-9011-10eec3ecb30f	1	2021-12-08
63323-321-10	EA - Each	63323-321	39fc3b1f-87de-48e0-876a-de660dbc6b0b	1	2012-07-24
63323-321-12	EA - Each	63323-321	b3ba8ab7-008d-430e-a375-60326f0daeb8	1	2021-12-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	2
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-321	POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	4	Current NDC, Legacy NDC, 2 package rows	20210319_fbc12c18-567b-41bc-89d0-efd29616615c.zip
63323-321	POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	1	Current NDC, Legacy NDC, 2 package rows	20210610_704a41f5-b109-4c16-8d3e-1495c9917952.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POLYMYXIN B	POLYMYXIN B SULFATE	Fresenius Kabi USA, LLC	704a41f5-b109-4c16-8d3e-1495c9917952	2021-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065372 application number: ANDA065372 ndc (product): 63323-321
POLYMYXIN B	POLYMYXIN B SULFATE	Fresenius Kabi USA, LLC	fbc12c18-567b-41bc-89d0-efd29616615c	2021-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065372 application number: ANDA065372 ndc (product): 63323-321

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	fbc12c18-567b-41bc-89d0-efd29616615c	4
204509	polymyxin B 250000 UNT/ML Injectable Solution	SCD	fbc12c18-567b-41bc-89d0-efd29616615c	4
204509	polymyxin B Variable Concentration Multi-Use Injectable Solution	PSN	704a41f5-b109-4c16-8d3e-1495c9917952	1
204509	polymyxin B 250000 UNT/ML Injectable Solution	SCD	704a41f5-b109-4c16-8d3e-1495c9917952	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-321-01	63323032101	1 in 1 VIAL						Historical
63323-321-02	63323032102	1 in 1 VIAL						Historical
63323-321-10	63323032110	10 VIAL in 1 TRAY (63323-321-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-01)	10 vial	2009-11-17	0000-00-00	No	No	Current
63323-321-12	63323032112	10 VIAL in 1 TRAY (63323-321-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-02)	10 vial	2009-11-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POLYMYXIN B - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2021-05-31	HUMAN PRESCRIPTION DRUG LABEL	1
POLYMYXIN B - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2021-02-28	HUMAN PRESCRIPTION DRUG LABEL	4