Polymyxin B Sulfate and Trimethoprim

Product NDC: 68071-4103
Requested package NDC: 68071-4103-5
11-digit product format: 680714103
Labeler code: 68071
Product ID: 68071-4103_1d8e3ec4-a0b3-e6d9-e063-6294a90aeab8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Polymyxin B Sulfate and Trimethoprim
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA064211
Marketing category: ANDA
Marketing start: 1998-04-16
Substance: POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength: 10000; 1 [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: 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
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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064211-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-04-13	`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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064211-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Polymyxin B Sulfate and Trimethoprim
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIMETHOPRIM SULFATE	10000 [USP'U]/mL
POLYMYXIN B SULFATE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
E377MF8EQ8	Internal UNII lookup
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
244967	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
60f5cfcf-cdb2-0e45-e053-2991aa0ae85a	Available on FDA.report

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#

Effective, Related label table
Effective	Related label
2023-07-13	Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile
2023-01-30	Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile
2021-02-12	Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile
2021-01-29	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
68071-4103-5	Polymyxin B Sulfate and Trimethoprim	10 mL in 1 BOX	SOLUTION	10		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4103	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [NUCARE PHARMACEUTICALS,INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240720_60f5cfcf-cdb2-0e45-e053-2991aa0ae85a.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	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	Preferred Pharmacetucials Inc.	65293418-c6ad-43d8-948c-e1949c0afc31	2025-09-09	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 ndc (package): 68071-4103-5 ndc (product): 68071-4103 ndc11 (package): 68071410305
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	60f5cfcf-cdb2-0e45-e053-2991aa0ae85a	6
244967	polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution	SCD	60f5cfcf-cdb2-0e45-e053-2991aa0ae85a	6
244967	polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution	SY	60f5cfcf-cdb2-0e45-e053-2991aa0ae85a	6
244967	polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution	SY	60f5cfcf-cdb2-0e45-e053-2991aa0ae85a	6
244967	Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution	SY	60f5cfcf-cdb2-0e45-e053-2991aa0ae85a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4103-5	68071410305	10 mL in 1 BOX (68071-4103-5)	10 ml	2017-12-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile	NuCare Pharmaceuticals,Inc.	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	6