NEO-POLY-BAC HYDRO

Product NDC
11695-1406
11-digit product format
116951406
Labeler code
11695
Product ID
11695-1406_6541631a-6c77-44fc-b6ac-3b91e42e3065
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Butler Animal Health Supply
Application
ANDA064068
Marketing category
ANDA
Marketing start
1995-10-30
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE
Active strength
4 mg/g; [USP'U]/g; [USP'U]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
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fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
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61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11695-1406-62019-10-29C16284748780-1960f7f55-c31d-8e05-e053-dbdaa90a074aNeomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11695-1406-6NEO-POLY-BAC HYDRO1 in 1 CARTONOINTMENT11
11695-1406-6NEO-POLY-BAC HYDRO3.5 g in 1 TUBEOINTMENT3.51

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESNEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJNEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1
BACITRACINACTIVE MOIETY58H6RWO52INEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJNEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1
NEOMYCINACTIVE MOIETYI16QD7X297NEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11695-1406NEO-POLY-BAC HYDRO (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE) OINTMENT [BUTLER ANIMAL HEALTH SUPPLY]1Legacy NDC, 2 package rows20101130_6541631a-6c77-44fc-b6ac-3b91e42e3065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116150bacitracin zinc 400 UNT / hydrocortisone acetate 10 MG / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN6541631a-6c77-44fc-b6ac-3b91e42e30651
1116150bacitracin zinc 0.4 UNT/MG / hydrocortisone acetate 0.01 MG/MG / neomycin sulfate 0.0035 MG/MG / polymyxin B sulfate 10 UNT/MG Ophthalmic OintmentSCD6541631a-6c77-44fc-b6ac-3b91e42e30651
1116150bacitracin zinc 400 UNT/GM / hydrocortisone acetate 1 % / neomycin sulfate 3.5 MG/GM / polymyxin B sulfate 10,000 UNT/GM Ophthalmic OintmentSY6541631a-6c77-44fc-b6ac-3b91e42e30651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11695-1406-6116951406061 in 1 CARTONHistorical