Trimethoprim sulfate and Polymyxin B sulfate

Product NDC: 63187-193
11-digit product format: 631870193
Labeler code: 63187
Product ID: 63187-193_a0deddd4-f2c7-4594-ac0d-1ed4ce48b891
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trimethoprim sulfate and Polymyxin B sulfate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Proficient Rx LP
Application: ANDA065006
Marketing category: ANDA
Marketing start: 1998-12-17
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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIMETHOPRIM SULFATE	1 mg/mL
POLYMYXIN B SULFATE	10000 [USP'U]/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
2c5579eb-ad81-415e-8dcb-9f1c94c897ae	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-193-10	Trimethoprim sulfate and Polymyxin B sulfate	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10		3
63187-193-10	Trimethoprim sulfate and Polymyxin B sulfate	1 in 1 CARTON	SOLUTION	1		3

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 [PROFICIENT RX LP]	1
Trimethoprim sulfate	ACTIVE INGREDIENT	E377MF8EQ8	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
Trimethoprim	ACTIVE MOIETY	AN164J8Y0X	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-193	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE SOLUTION [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 2 package rows	20210121_2c5579eb-ad81-415e-8dcb-9f1c94c897ae.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 ndc (product): 63187-193

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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-193-10	63187019310	1 BOTTLE, DROPPER in 1 CARTON (63187-193-10) / 10 mL in 1 BOTTLE, DROPPER	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3