Chlorhexidine Gluconate

Product NDC
53002-5110
11-digit product format
530025110
Labeler code
53002
Product ID
53002-5110_33151dda-7a21-43a6-ad5b-ceeb05063d24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
RINSE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077789
Marketing category
ANDA
Marketing start
2010-06-01
Marketing end
0000-00-00
Substance
CHLORHEXIDINE GLUCONATE
Active strength
1 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-5110-1Chlorhexidine Gluconate473 mL in 1 BOTTLERINSE4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-5110CHLORHEXIDINE GLUCONATE RINSE [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_35a91066-ca19-444c-8f56-6fad45fc6585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834127chlorhexidine gluconate 0.12 % Oral RinsePSN35a91066-ca19-444c-8f56-6fad45fc65855
834127chlorhexidine gluconate 1.2 MG/ML MouthwashSCD35a91066-ca19-444c-8f56-6fad45fc65855
834127chlorhexidine gluconate 0.12 % MouthwashSY35a91066-ca19-444c-8f56-6fad45fc65855
834127chlorhexidine gluconate 0.12 % Oral RinseSY35a91066-ca19-444c-8f56-6fad45fc65855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-5110-153002511001473 mL in 1 BOTTLE (53002-5110-1) 473 ml2018-10-010000-00-00NoNoCurrent