Polymyxin B Sulfate and Trimethoprim

Product NDC: 21695-335
11-digit product format: 216950335
Labeler code: 21695
Product ID: 21695-335_cf4bd790-291e-4c35-83bb-205fb06753b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: polymyxin B sulfate and trimethoprim
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Rebel Distributors Corp
Application: ANDA064211
Marketing category: ANDA
Marketing start: 1998-04-13
Marketing end: 0000-00-00
Substance: POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength: 10000 mL/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: E
Listing certified through: 2017-12-31
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	21695-335		I	Inactivated by FDA		2026-09-09
excluded package	package	21695-335	21695-335-10	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 · 44 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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`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	21695-335-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-335-10	`110d247fa046…`	`a55b01930146…`

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
8d30c4f0-0228-cea4-e3aa-f19064c47f27	Product name	3	20221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fad	Product name	3	20190926
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-335-10	2019-09-24	C162847	48780-1	934fe258-4a37-48b1-e053-8cdaa90a720a	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
21695-335-10	Polymyxin B Sulfate and Trimethoprim	10 mL in 1 BOTTLE, PLASTIC	SOLUTION	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-335-10	ML - Milliliter	21695-335	bb010707-cd3d-4e7a-b595-b305b928f32a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
polymyxin B sulfate	ACTIVE INGREDIENT	19371312D4	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1
trimethoprim sulfate	ACTIVE INGREDIENT	E377MF8EQ8	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1
polymyxin B	ACTIVE MOIETY	J2VZ07J96K	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1
trimethoprim	ACTIVE MOIETY	AN164J8Y0X	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1
sulfuric acid	INACTIVE INGREDIENT	O40UQP6WCF	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-335	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110113_cf4bd790-291e-4c35-83bb-205fb06753b6.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	cf4bd790-291e-4c35-83bb-205fb06753b6	1
244967	polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution	SCD	cf4bd790-291e-4c35-83bb-205fb06753b6	1
244967	polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution	SY	cf4bd790-291e-4c35-83bb-205fb06753b6	1
244967	polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution	SY	cf4bd790-291e-4c35-83bb-205fb06753b6	1
244967	Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution	SY	cf4bd790-291e-4c35-83bb-205fb06753b6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-335-10	21695033510	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	Rebel Distributors Corp	2011-01-04	HUMAN PRESCRIPTION DRUG LABEL	1