FDA.reportPublic FDA data

Polymyxin B Sulfate and Trimethoprim

Product NDC
61314-628
11-digit product format
613140628
Labeler code
61314
Product ID
61314-628_4d36bcb4-0517-40ad-8c6e-74ca25ddae74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B Sulfate and Trimethoprim
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Sandoz 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

Additional Listing Data#

Finished product
Yes
Brand name base
Polymyxin B Sulfate and Trimethoprim
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B SULFATE10000 [USP'U]/mL
TRIMETHOPRIM SULFATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19371312D4, E377MF8EQ8
Rxcui244967

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-628-10Polymyxin B Sulfate and Trimethoprim10 mL in 1 BOTTLE, PLASTICSOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-628-10ML - Milliliter61314-628c54b15ba-7d0e-4b0b-b0fd-790f23c7eb6812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [FALCON PHARMACEUTICALS, LTD.]3
TRIMETHOPRIM SULFATEACTIVE INGREDIENTE377MF8EQ8POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [FALCON PHARMACEUTICALS, LTD.]3
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [FALCON PHARMACEUTICALS, LTD.]3
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [FALCON PHARMACEUTICALS, LTD.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [FALCON PHARMACEUTICALS, LTD.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [FALCON PHARMACEUTICALS, LTD.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [FALCON PHARMACEUTICALS, LTD.]3
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [FALCON PHARMACEUTICALS, LTD.]3
WATERINACTIVE INGREDIENT059QF0KO0RPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [FALCON PHARMACEUTICALS, LTD.]3
polymyxin B sulfateACTIVE INGREDIENT19371312D4POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [STAT RX LLC USA]1
trimethoprim sulfateACTIVE INGREDIENTE377MF8EQ8POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1
TRIMETHOPRIM SULFATEACTIVE INGREDIENTE377MF8EQ8POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [STAT RX LLC USA]1
polymyxin BACTIVE MOIETYJ2VZ07J96KPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [STAT RX LLC USA]1
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [STAT RX LLC USA]1
trimethoprimACTIVE MOIETYAN164J8Y0XPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [STAT RX LLC USA]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [STAT RX LLC USA]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [STAT RX LLC USA]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [STAT RX LLC USA]1
sulfuric acidINACTIVE INGREDIENTO40UQP6WCFPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [STAT RX LLC USA]1
waterINACTIVE INGREDIENT059QF0KO0RPOLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-628POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [SANDOZ INC]6Current NDC, Legacy NDC, 1 package rows20220216_71900075-5288-4f4b-afe2-098436fa2173.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSNaaa468d2-470f-43cf-b4e2-68aeb94a1e7114
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCDaaa468d2-470f-43cf-b4e2-68aeb94a1e7114
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSYaaa468d2-470f-43cf-b4e2-68aeb94a1e7114
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSYaaa468d2-470f-43cf-b4e2-68aeb94a1e7114
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSYaaa468d2-470f-43cf-b4e2-68aeb94a1e7114
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN2a040ba4-54bd-41e4-b519-01ca6a59658f11
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD2a040ba4-54bd-41e4-b519-01ca6a59658f11
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY2a040ba4-54bd-41e4-b519-01ca6a59658f11
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY2a040ba4-54bd-41e4-b519-01ca6a59658f11
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY2a040ba4-54bd-41e4-b519-01ca6a59658f11
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN65293418-c6ad-43d8-948c-e1949c0afc319
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD65293418-c6ad-43d8-948c-e1949c0afc319
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY65293418-c6ad-43d8-948c-e1949c0afc319
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY65293418-c6ad-43d8-948c-e1949c0afc319
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY65293418-c6ad-43d8-948c-e1949c0afc319
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN60f5cfcf-cdb2-0e45-e053-2991aa0ae85a6
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD60f5cfcf-cdb2-0e45-e053-2991aa0ae85a6
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY60f5cfcf-cdb2-0e45-e053-2991aa0ae85a6
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY60f5cfcf-cdb2-0e45-e053-2991aa0ae85a6
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY60f5cfcf-cdb2-0e45-e053-2991aa0ae85a6
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN76e1be2e-eb19-48d4-9bfb-88537de839ba5
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD76e1be2e-eb19-48d4-9bfb-88537de839ba5
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY76e1be2e-eb19-48d4-9bfb-88537de839ba5
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY76e1be2e-eb19-48d4-9bfb-88537de839ba5
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY76e1be2e-eb19-48d4-9bfb-88537de839ba5
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN1252b997-3a81-4f3c-90e4-92f29ba157134
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD1252b997-3a81-4f3c-90e4-92f29ba157134
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY1252b997-3a81-4f3c-90e4-92f29ba157134
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY1252b997-3a81-4f3c-90e4-92f29ba157134
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY1252b997-3a81-4f3c-90e4-92f29ba157134
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN12de69e0-e8de-4871-833b-30cc4a0a69652
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD12de69e0-e8de-4871-833b-30cc4a0a69652
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY12de69e0-e8de-4871-833b-30cc4a0a69652
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY12de69e0-e8de-4871-833b-30cc4a0a69652
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY12de69e0-e8de-4871-833b-30cc4a0a69652
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN1bc42aac-28fa-9f32-e063-6394a90a05561
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSNcf4bd790-291e-4c35-83bb-205fb06753b61
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD1bc42aac-28fa-9f32-e063-6394a90a05561
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCDcf4bd790-291e-4c35-83bb-205fb06753b61
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY1bc42aac-28fa-9f32-e063-6394a90a05561
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSYcf4bd790-291e-4c35-83bb-205fb06753b61
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY1bc42aac-28fa-9f32-e063-6394a90a05561
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSYcf4bd790-291e-4c35-83bb-205fb06753b61
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY1bc42aac-28fa-9f32-e063-6394a90a05561
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSYcf4bd790-291e-4c35-83bb-205fb06753b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-628-106131406281010 mL in 1 BOTTLE, PLASTIC (61314-628-10) 10 ml1998-04-160000-00-00NoNoCurrent