FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates and Dexamethasone

Product NDC
61314-631
11-digit product format
613140631
Labeler code
61314
Product ID
61314-631_247c1988-9ae8-4e3c-80a0-7d88545fe6b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin and Polymyxin B Sulfates and Dexamethasone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
NDA050065
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1996-02-21
Substance
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
1; 3.5; 10000 mg/g; mg/g; [iU]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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
Neomycin and Polymyxin B Sulfates and Dexamethasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXAMETHASONE1 mg/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [iU]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S5I7G3JQL, 057Y626693, 19371312D4
Rxcui309679

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-631-36Neomycin and Polymyxin B Sulfates and Dexamethasone3.5 g in 1 TUBEOINTMENT3.56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-631-36GM - Gram61314-63142339d82-34e2-4fce-8d84-6f54fbe705ae12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXAMETHASONEACTIVE INGREDIENT7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1
DEXAMETHASONEACTIVE MOIETY7S5I7G3JQLNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [FALCON PHARMACEUTICALS, LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-631NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT [SANDOZ INC]5Current NDC, Legacy NDC, 1 package rows20241123_7f2e3c46-9f39-45e7-99a9-64cc4f6f649d.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 OintmentPSN6791e6c3-514d-4b98-8887-ca2b894576b56
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN7f2e3c46-9f39-45e7-99a9-64cc4f6f649d6
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD6791e6c3-514d-4b98-8887-ca2b894576b56
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD7f2e3c46-9f39-45e7-99a9-64cc4f6f649d6
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY6791e6c3-514d-4b98-8887-ca2b894576b56
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY7f2e3c46-9f39-45e7-99a9-64cc4f6f649d6
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNa7e55c43-4345-4710-e053-2995a90aeee74
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDa7e55c43-4345-4710-e053-2995a90aeee74
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYa7e55c43-4345-4710-e053-2995a90aeee74
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSNaa7b8a3f-06dd-4190-96a5-f86195bd21972
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCDaa7b8a3f-06dd-4190-96a5-f86195bd21972
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSYaa7b8a3f-06dd-4190-96a5-f86195bd21972
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN1fc00d4f-df24-1fb8-e063-6294a90aaee21
309679dexAMETHasone 1 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN947bcaeb-59da-332e-e053-2995a90aab811
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD947bcaeb-59da-332e-e053-2995a90aab811
309679dexamethasone 0.001 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD1fc00d4f-df24-1fb8-e063-6294a90aaee21
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY947bcaeb-59da-332e-e053-2995a90aab811
309679dexamethasone 0.1 % / neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10 UNT/MG Ophthalmic OintmentSY1fc00d4f-df24-1fb8-e063-6294a90aaee21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-631-36613140631363.5 g in 1 TUBE (61314-631-36) 3.5 g1996-02-210000-00-00NoNoCurrent