FDA.reportPublic FDA data

Neomycin and Polymyxin B Sulfates and Gramicidin

Product NDC
21695-528
11-digit product format
216950528
Labeler code
21695
Product ID
21695-528_65edc059-0806-4625-b583-0e36f04cf085
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Neomycin sulfate, Polymyxin B Sulfate and Gramicidin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
ANDA064047
Marketing category
ANDA
Marketing start
1996-01-31
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; GRAMICIDIN
Active strength
2 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
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
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-528-102019-09-24C16284748780-1934fe258-4719-48b1-e053-8cdaa90a720aNeomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-528-10Neomycin and Polymyxin B Sulfates and Gramicidin1 in 1 CARTONSOLUTION/ DROPS11
21695-528-10Neomycin and Polymyxin B Sulfates and Gramicidin10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-528-10ML - Milliliter21695-528aee17fa7-f37f-4cad-abda-ad28113e6d2512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GramicidinACTIVE INGREDIENT5IE62321P4NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Neomycin SulfateACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
GramicidinACTIVE MOIETY5IE62321P4NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
NeomycinACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
AlcoholINACTIVE INGREDIENT3K9958V90MNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
ThimerosalINACTIVE INGREDIENT2225PI3MOVNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RNEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-528NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110113_65edc059-0806-4625-b583-0e36f04cf085.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310594gramicidin 0.025 MG / neomycin sulfate 1.75 MG / polymyxin B sulfate 10,000 UNT per ML Ophthalmic SolutionPSN65edc059-0806-4625-b583-0e36f04cf0851
310594gramicidin 0.025 MG/ML / neomycin 1.75 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic SolutionSCD65edc059-0806-4625-b583-0e36f04cf0851
310594gramicidin 0.025 MG / neomycin (as neomycin sulfate) 1.75 MG / polymyxin B (as polymyxin B sulfate) 10,000 UNT per ML Ophthalmic SolutionSY65edc059-0806-4625-b583-0e36f04cf0851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-528-10216950528101 in 1 CARTONHistorical