FDA.reportPublic FDA data

POLYCIN

Product NDC
61919-111
11-digit product format
619190111
Labeler code
61919
Product ID
61919-111_9caca195-3508-1c39-e053-2a95a90ad3dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bacitracin zinc and polymyxin b sulfates
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
DIRECT RX
Application
ANDA065022
Marketing category
ANDA
Marketing start
2017-03-29
Marketing end
0000-00-00
Substance
POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength
10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes
Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-111-352023-01-30C16284748780-1f386c64a-0d8f-0266-e053-dadaa90a7c1aPOLYCIN OPTH OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-111-35POLYCIN1 g in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-111-35GM - Gram61919-11167857635-2d3a-4193-b6c6-fb4e23f04b5512019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-111POLYCIN (BACITRACIN ZINC AND POLYMYXIN B SULFATES) OINTMENT [DIRECT RX]2Legacy NDC, 1 package rows20200122_4be2ae47-ce1e-6212-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308511bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic OintmentPSN4be2ae47-ce1e-6212-e054-00144ff88e882
213621Polycin 500 UNT/GM / 10,000 UNT/GM Ophthalmic OintmentPSN4be2ae47-ce1e-6212-e054-00144ff88e882
213621bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Polycin]SBD4be2ae47-ce1e-6212-e054-00144ff88e882
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD4be2ae47-ce1e-6212-e054-00144ff88e882
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY4be2ae47-ce1e-6212-e054-00144ff88e882
213621Polycin-B (bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM) Ophthalmic OintmentSY4be2ae47-ce1e-6212-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-111-35619190111351 g in 1 CARTON (61919-111-35) 1 g2017-03-290000-00-00NoNoCurrent