POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE

Product NDC
60758-908
11-digit product format
607580908
Labeler code
60758
Product ID
60758-908_4bda8610-a14c-45ca-8caa-5fb3afce314e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
polymyxin B sulfate, trimethoprim sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Pacific Pharma, Inc.
Application
NDA050567
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1997-04-29
Marketing end
0000-00-00
Substance
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active strength
10000 [USP'U]/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
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
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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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60758-908-10ML - Milliliter60758-908c9a05a15-dd5c-4c45-a7ec-3e91a548722112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
polymyxin B sulfateACTIVE INGREDIENT19371312D4POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
trimethoprim sulfateACTIVE INGREDIENTE377MF8EQ8POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
polymyxin BACTIVE MOIETYJ2VZ07J96KPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
trimethoprimACTIVE MOIETYAN164J8Y0XPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
sulfuric acidINACTIVE INGREDIENTO40UQP6WCFPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE (POLYMYXIN B SULFATE, TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN0461401a-17c1-460f-b9ec-ff1cfe514f572
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD0461401a-17c1-460f-b9ec-ff1cfe514f572
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY0461401a-17c1-460f-b9ec-ff1cfe514f572
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY0461401a-17c1-460f-b9ec-ff1cfe514f572
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY0461401a-17c1-460f-b9ec-ff1cfe514f572
244967polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic SolutionPSN1fc0731a-fb78-240f-e063-6394a90a69501
244967polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic SolutionSCD1fc0731a-fb78-240f-e063-6394a90a69501
244967polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic SolutionSY1fc0731a-fb78-240f-e063-6394a90a69501
244967polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic SolutionSY1fc0731a-fb78-240f-e063-6394a90a69501
244967Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic SolutionSY1fc0731a-fb78-240f-e063-6394a90a69501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60758-908-10607580908101 BOTTLE, DROPPER in 1 CARTON (60758-908-10) > 10 mL in 1 BOTTLE, DROPPER1997-04-290000-00-00NoNoCurrent