Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate

Product NDC
21695-736
11-digit product format
216950736
Labeler code
21695
Product ID
21695-736_bdee074e-e813-4403-897c-1ccb32bd6548
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin sulfate and Polymyxin B Sulfate, Bacitracin zinc and Hydrocortisone Acetate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA062166
Marketing category
ANDA
Marketing start
1981-04-14
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC; HYDROCORTISONE ACETATE
Active strength
4 mg/g; g/g; g/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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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-736-352019-09-24C16284748780-1934fe258-4bd5-48b1-e053-8cdaa90a720aNEOMYCIN and POLYMYXIN B SULFATES and BACITRACIN ZINC with HYDROCORTISONE ACETATE OPHTHALMIC OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-736-35Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate3.5 g in 1 TUBEOINTMENT3.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-736-35GM - Gram21695-73672dcd4a4-8fa8-4d97-b82c-3ac5b5384fde12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin zincACTIVE INGREDIENT89Y4M234ESNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Hydrocortisone AcetateACTIVE INGREDIENT3X7931PO74NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Neomycin SulfateACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
bacitracinACTIVE MOIETY58H6RWO52INEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
hydrocortisoneACTIVE MOIETYWI4X0X7BPJNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
neomycinACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
polymyxin BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1
Zinc chlorideINACTIVE INGREDIENT86Q357L16BNEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-736NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE (NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE ACETATE) OINTMENT [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_bdee074e-e813-4403-897c-1ccb32bd6548.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 OintmentPSNbdee074e-e813-4403-897c-1ccb32bd65481
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 OintmentSCDbdee074e-e813-4403-897c-1ccb32bd65481
1116150bacitracin zinc 400 UNT/GM / hydrocortisone acetate 1 % / neomycin sulfate 3.5 MG/GM / polymyxin B sulfate 10,000 UNT/GM Ophthalmic OintmentSYbdee074e-e813-4403-897c-1ccb32bd65481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-736-35216950736353.5 g in 1 TUBE3.5 gHistorical