FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension

Product NDC
64980-448
11-digit product format
649800448
Labeler code
64980
Product ID
64980-448_4b15047c-4c19-4562-ba03-5c1aff192a2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neomycin and polymyxin B sulfates and hydrocortisone otic
Dosage form
SUSPENSION
Route
AURICULAR (OTIC)
Labeler
Rising Pharma Holdings, Inc.
Application
NDA060613
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-03-15
Substance
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/mL
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 Hydrocortisone Otic Suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE10 mg/mL
NEOMYCIN SULFATE3.5 mg/mL
POLYMYXIN B SULFATE10000 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWI4X0X7BPJ, 057Y626693, 19371312D4
Rxcui310687

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-448-01Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension1 in 1 CARTONSUSPENSION15
64980-448-01Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension10 mL in 1 BOTTLESUSPENSION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-448-01ML - Milliliter64980-4483c4faa4c-da58-46e7-b021-a52fd786c92f12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-448NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION (NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC) SUSPENSION [RISING PHARMA HOLDINGS, INC.]5Current NDC, Legacy NDC, 2 package rows20240620_35768adc-b578-4c2e-b461-22de3135a789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSN5f17fae0-c6ea-452e-b84f-066caf2a95fc6
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCD5f17fae0-c6ea-452e-b84f-066caf2a95fc6
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSY5f17fae0-c6ea-452e-b84f-066caf2a95fc6
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSN35768adc-b578-4c2e-b461-22de3135a7895
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCD35768adc-b578-4c2e-b461-22de3135a7895
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSY35768adc-b578-4c2e-b461-22de3135a7895
310687hydrocortisone 10 MG (1 % ) / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per mL Otic SuspensionPSNc895676f-446a-4a93-a3d2-addcce96b1081
310687hydrocortisone 10 MG/ML / neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML Otic SuspensionSCDc895676f-446a-4a93-a3d2-addcce96b1081
310687hydrocortisone 10 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per 1 ML Otic SuspensionSYc895676f-446a-4a93-a3d2-addcce96b1081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-448-01649800448011 BOTTLE in 1 CARTON (64980-448-01) / 10 mL in 1 BOTTLE1 bottle2019-03-150000-00-00NoNoCurrent