POLYMYXIN B SULFATE AND TRIMETHOPRIM

Product NDC: 17478-703
11-digit product format: 174780703
Labeler code: 17478
Product ID: 17478-703_2f983ff2-7010-48e2-ac6b-b1343a0915f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: polymyxin b sulfate and trimethoprim
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Akorn
Application: ANDA065006
Marketing category: ANDA
Marketing start: 1998-12-17
Marketing end: 0000-00-00
Substance: POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength: 10000 [USP'U]/mL; mg/mL
Pharmacologic classes: Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	17478-703		I	Inactivated by FDA		2026-08-17
excluded package	package	17478-703	17478-703-11	I	Inactivated by FDA		2026-08-17

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 · 30 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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`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	17478-703-11	`1332a3947898…`	`d4bfe170f9cd…`

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
A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065006-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`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	A065006-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065006-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065006-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065006-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065006-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065006-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065006-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065006-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065006-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065006-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065006-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065006-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065006-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065006-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065006-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065006-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065006-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065006-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065006-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065006-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065006-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065006-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065006-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065006-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065006-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065006-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065006-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065006-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065006-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065006-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065006-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065006-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065006-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065006-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065006-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065006-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065006-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065006-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065006-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065006-001	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
17478-703-11	2024-01-30	C162847	48780-1	1030e365-5a3b-111a-e063-dadaa90a10e2	Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-703-11	POLYMYXIN B SULFATE AND TRIMETHOPRIM	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10		9
17478-703-11	POLYMYXIN B SULFATE AND TRIMETHOPRIM	1 in 1 CARTON	SOLUTION	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-703-11	ML - Milliliter	17478-703	9e844551-b9ea-478b-a43c-72ee81e59018	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Polymyxin B sulfate	ACTIVE INGREDIENT	19371312D4	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [AKORN, INC.]	2
Trimethoprim sulfate	ACTIVE INGREDIENT	E377MF8EQ8	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [AKORN, INC.]	2
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [AKORN, INC.]	2
Trimethoprim	ACTIVE MOIETY	AN164J8Y0X	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [AKORN, INC.]	2
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [AKORN, INC.]	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [AKORN, INC.]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [AKORN, INC.]	2
sulfuric acid	INACTIVE INGREDIENT	O40UQP6WCF	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [AKORN, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [AKORN, INC.]	2
Polymyxin B sulfate	ACTIVE INGREDIENT	19371312D4	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1
Trimethoprim sulfate	ACTIVE INGREDIENT	E377MF8EQ8	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
TRIMETHOPRIM SULFATE	ACTIVE INGREDIENT	E377MF8EQ8	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1
Trimethoprim	ACTIVE MOIETY	AN164J8Y0X	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1
sulfuric acid	INACTIVE INGREDIENT	O40UQP6WCF	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1
sulfuric acid	INACTIVE INGREDIENT	O40UQP6WCF	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-703	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [AKORN]	9	Legacy NDC, 2 package rows	20220706_507c7308-6526-40d7-b8aa-3ca7b5d8cc17.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trimethoprim sulfate and Polymyxin B sulfate	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	Proficient Rx LP	2c5579eb-ad81-415e-8dcb-9f1c94c897ae	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065006 application number: ANDA065006

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	507c7308-6526-40d7-b8aa-3ca7b5d8cc17	9
244967	polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution	SCD	507c7308-6526-40d7-b8aa-3ca7b5d8cc17	9
244967	polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution	SY	507c7308-6526-40d7-b8aa-3ca7b5d8cc17	9
244967	polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution	SY	507c7308-6526-40d7-b8aa-3ca7b5d8cc17	9
244967	Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution	SY	507c7308-6526-40d7-b8aa-3ca7b5d8cc17	9
244967	polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic Solution	PSN	2c5579eb-ad81-415e-8dcb-9f1c94c897ae	3
244967	polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution	SCD	2c5579eb-ad81-415e-8dcb-9f1c94c897ae	3
244967	polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution	SY	2c5579eb-ad81-415e-8dcb-9f1c94c897ae	3
244967	polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution	SY	2c5579eb-ad81-415e-8dcb-9f1c94c897ae	3
244967	Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution	SY	2c5579eb-ad81-415e-8dcb-9f1c94c897ae	3
244967	polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic Solution	PSN	8c27962d-62b5-30e6-e053-2a95a90a49c6	1
244967	polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution	SCD	8c27962d-62b5-30e6-e053-2a95a90a49c6	1
244967	polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution	SY	8c27962d-62b5-30e6-e053-2a95a90a49c6	1
244967	polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution	SY	8c27962d-62b5-30e6-e053-2a95a90a49c6	1
244967	Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution	SY	8c27962d-62b5-30e6-e053-2a95a90a49c6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-703-11	17478070311	1 BOTTLE, DROPPER in 1 CARTON (17478-703-11) > 10 mL in 1 BOTTLE, DROPPER	1998-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution	Akorn	2022-07-01	HUMAN PRESCRIPTION DRUG LABEL	9
Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution	Preferred Pharmaceuticals Inc.	2020-10-09	HUMAN PRESCRIPTION DRUG LABEL	4
Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution	REMEDYREPACK INC.	2020-05-19	HUMAN PRESCRIPTION DRUG LABEL	4
POLYMYXIN B SULFATE AND TRIMETHOPRIM	Direct_Rx	2019-06-25	HUMAN PRESCRIPTION DRUG LABEL	1