Polymyxin B Sulfate and Trimethoprim

Product NDC: 53217-305
11-digit product format: 532170305
Labeler code: 53217
Product ID: 53217-305_08a728cf-c494-47e8-b725-a6d8632bcbcf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Polymyxin B Sulfate and Trimethoprim
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA064211
Marketing category: ANDA
Marketing start: 2017-04-27
Marketing end: 0000-00-00
Substance: POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength: 10000 [USP'U]/mL; mg/mL
Pharmacologic classes: Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
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	53217-305		I	Inactivated by FDA		2026-09-09
excluded package	package	53217-305	53217-305-01	I	Inactivated by FDA		2026-09-09

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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`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	53217-305-01	`9bebd1f3094a…`	`5416666fcb17…`

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
A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064211-001	AT

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	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1998-04-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`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	A064211-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064211-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064211-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064211-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064211-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064211-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064211-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064211-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064211-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064211-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064211-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064211-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064211-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064211-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064211-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064211-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064211-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064211-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064211-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064211-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064211-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064211-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064211-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064211-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064211-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064211-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064211-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064211-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064211-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064211-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064211-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064211-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064211-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064211-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064211-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064211-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064211-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064211-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064211-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064211-001	AT	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ce811b5-329e-27f8-b5ff-66d52b435c00	Product name	3	20240108
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
8d30c4f0-0228-cea4-e3aa-f19064c47f27	Product name	3	20221128
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e20c430-5e8f-85da-1b03-f7dbc0c51fad	Product name	3	20190926
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-305-01	2020-01-31	C162847	48780-1	9d75b9cf-cf8f-f424-e053-dadaa90a57ce	Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-305-01	Polymyxin B Sulfate and Trimethoprim	10 mL in 1 BOTTLE, PLASTIC	SOLUTION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-305	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [AIDAREX PHARMACEUTICALS LLC]	2	Legacy NDC, 1 package rows	20180524_12de69e0-e8de-4871-833b-30cc4a0a6965.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Polymyxin B Sulfate and Trimethoprim	POLYMYXIN B SULFATE AND TRIMETHOPRIM	Preferred Pharmacetucials Inc.	65293418-c6ad-43d8-948c-e1949c0afc31	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064211 application number: ANDA064211
Polymyxin B Sulfate and Trimethoprim	POLYMYXIN B SULFATE AND TRIMETHOPRIM	A-S Medication Solutions	aaa468d2-470f-43cf-b4e2-68aeb94a1e71	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064211 application number: ANDA064211
Polymyxin B Sulfate and Trimethoprim	POLYMYXIN B SULFATE AND TRIMETHOPRIM	REMEDYREPACK INC.	2a040ba4-54bd-41e4-b519-01ca6a59658f	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064211 application number: ANDA064211
Polymyxin B Sulfate and Trimethoprim	POLYMYXIN B SULFATE AND TRIMETHOPRIM	Sandoz Inc	71900075-5288-4f4b-afe2-098436fa2173	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064211 application number: ANDA064211
Polymyxin B Sulfate and Trimethoprim	POLYMYXIN B SULFATE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	60f5cfcf-cdb2-0e45-e053-2991aa0ae85a	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064211 application number: ANDA064211
Polymyxin B Sulfate and Trimethoprim	POLYMYXIN B SULFATE AND TRIMETHOPRIM	Proficient Rx LP	1252b997-3a81-4f3c-90e4-92f29ba15713	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064211 application number: ANDA064211

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE
E377MF8EQ8	TRIMETHOPRIM SULFATE	56585-33-2	TRIMETHOPRIM SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
244967	polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic Solution	PSN	12de69e0-e8de-4871-833b-30cc4a0a6965	2
244967	polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution	SCD	12de69e0-e8de-4871-833b-30cc4a0a6965	2
244967	polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution	SY	12de69e0-e8de-4871-833b-30cc4a0a6965	2
244967	polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution	SY	12de69e0-e8de-4871-833b-30cc4a0a6965	2
244967	Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution	SY	12de69e0-e8de-4871-833b-30cc4a0a6965	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53217-305-01	53217030501	10 mL in 1 BOTTLE, PLASTIC	10 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-05-21	HUMAN PRESCRIPTION DRUG LABEL	2