FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
0574-4160
11-digit product format
005744160
Labeler code
0574
Product ID
0574-4160_300ff594-23be-4bdd-9bf4-d5e71bc5a782
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin, Polymyxin B Sulfates, Dexamethasone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Padagis US LLC
Application
ANDA062938
Marketing category
ANDA
Marketing start
2014-07-03
Marketing end
0000-00-00
Substance
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
1 mg/g; mg/g; [USP'U]/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
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
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4160-35GM - Gram0574-4160efa5b018-0e45-4c8c-830f-bd942633733112014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADDOCK LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4160NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONE) OINTMENT [PADAGIS US LLC]5Legacy NDC20241107_c8ae4afe-4f06-4441-9c5b-52f485f8f2f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNd92683cc-b6e0-4e52-aefa-990f3369b4dc10
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDd92683cc-b6e0-4e52-aefa-990f3369b4dc10
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYd92683cc-b6e0-4e52-aefa-990f3369b4dc10
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNbd9f3220-6d42-4863-aa2a-b17b138d095d3
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDbd9f3220-6d42-4863-aa2a-b17b138d095d3
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYbd9f3220-6d42-4863-aa2a-b17b138d095d3
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN4aecebf1-2f64-725d-e054-00144ff8d46c2
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD4aecebf1-2f64-725d-e054-00144ff8d46c2
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY4aecebf1-2f64-725d-e054-00144ff8d46c2
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNc44aae7b-3241-4760-a11f-f620871f14661
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDc44aae7b-3241-4760-a11f-f620871f14661
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYc44aae7b-3241-4760-a11f-f620871f14661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-4160-35005744160351 TUBE in 1 CARTON (0574-4160-35) > 3.5 g in 1 TUBE1 tube2014-07-030000-00-00NoNoCurrent