POLYMYXIN B

Product NDC: 68083-174
11-digit product format: 680830174
Labeler code: 68083
Product ID: 68083-174_0f89d7be-ad20-46d1-8cce-0cee8ee572cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POLYMYXIN B SULFATE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Labeler: Gland Pharma Limited
Application: ANDA207322
Marketing category: ANDA
Marketing start: 2016-06-01
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
A207322-001	POLYMYXIN B SULFATE	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207322-001	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	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2016-04-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION	AP		2016-04-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207322-001	POLYMYXIN B SULFATE	EQ 500,000 UNITS BASE/VIAL	INJECTABLE / INJECTION			2016-04-14	`cb3db0bc1861…`

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	A207322-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207322-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207322-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207322-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207322-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207322-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207322-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207322-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207322-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207322-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207322-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207322-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207322-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207322-001	AP	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A207322-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207322-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207322-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207322-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207322-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207322-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207322-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207322-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207322-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207322-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207322-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207322-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207322-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207322-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207322-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207322-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207322-001	AP	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207322-001	AP	1	`a50c72e98297…`

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
dc74dee2-1d0b-4fab-a29b-1755fdb5da75	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	Strength	SPL version
68083-174-01	POLYMYXIN B	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1		9
68083-174-10	POLYMYXIN B	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-174	POLYMYXIN B (POLYMYXIN B SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]	9	Current NDC, Legacy NDC, 2 package rows	20250514_dc74dee2-1d0b-4fab-a29b-1755fdb5da75.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	Sagent Pharmaceuticals	7dc505aa-64b0-4b7f-8ee3-2945bde40a34	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207322 application number: ANDA207322
POLYMYXIN B	POLYMYXIN B SULFATE	FOSUN PHARMA USA INC	fd664927-db58-a1af-e053-6294a90a9048	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207322 application number: ANDA207322
POLYMYXIN B	POLYMYXIN B SULFATE	Gland Pharma Limited	dc74dee2-1d0b-4fab-a29b-1755fdb5da75	2025-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207322 application number: ANDA207322 ndc (product): 68083-174

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	dc74dee2-1d0b-4fab-a29b-1755fdb5da75	9
204509	polymyxin B 250000 UNT/ML Injectable Solution	SCD	dc74dee2-1d0b-4fab-a29b-1755fdb5da75	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-174-01	68083017401	1 in 1 VIAL						Historical
68083-174-10	68083017410	10 VIAL in 1 CARTON (68083-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01)	10 vial	2016-06-01	0000-00-00	No	No	Current