FDA.reportPublic FDA data

polycin

Product NDC
66267-925
11-digit product format
662670925
Labeler code
66267
Product ID
66267-925_1fa7a635-8d93-58f2-e063-6394a90ab77e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bacitracin zinc and polymyxin b sulfates
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065022
Marketing category
ANDA
Marketing start
2014-11-12
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE], 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
polycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui213621, 308511

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
66267-925-352024-08-14C16284748780-1f386c64a-22d6-0266-e053-dadaa90a7c1aPolycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only
66267-925-352023-01-30C16284748780-1f386c64a-22d6-0266-e053-dadaa90a7c1aPolycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-925-35polycin3.5 g in 1 TUBEOINTMENT3.55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-925-35GM - Gram66267-92502e24ccb-6495-4d65-877a-aed3eca6ed2312017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-925POLYCIN (BACITRACIN ZINC AND POLYMYXIN B SULFATES) OINTMENT [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20240816_5d55e918-98a0-4989-e053-2a91aa0a9ad7.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 OintmentPSN5d55e918-98a0-4989-e053-2a91aa0a9ad75
213621Polycin 500 UNT/GM / 10,000 UNT/GM Ophthalmic OintmentPSN5d55e918-98a0-4989-e053-2a91aa0a9ad75
213621bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Polycin]SBD5d55e918-98a0-4989-e053-2a91aa0a9ad75
308511bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic OintmentSCD5d55e918-98a0-4989-e053-2a91aa0a9ad75
308511bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic OintmentSY5d55e918-98a0-4989-e053-2a91aa0a9ad75
213621Polycin-B (bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM) Ophthalmic OintmentSY5d55e918-98a0-4989-e053-2a91aa0a9ad75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-925-35662670925353.5 g in 1 TUBE (66267-925-35) 3.5 g2017-11-060000-00-00NoNoCurrent