Chlorhexidine Gluconate

Product NDC
0116-0101
11-digit product format
001160101
Labeler code
0116
Product ID
0116-0101_a1895aa7-b2bc-dc71-e053-2995a90a2e4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlorhexidine Gluconate
Dosage form
LIQUID
Route
ORAL
Labeler
Xttrium Laboratories, Inc.
Application
ANDA077789
Marketing category
ANDA
Marketing start
2016-01-22
Substance
CHLORHEXIDINE GLUCONATE
Active strength
.12 mg/mL
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorhexidine Gluconate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORHEXIDINE GLUCONATE.12 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMOR84MUD8E

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0116-0101-01Chlorhexidine Gluconate473 mL in 1 BOTTLELIQUID4735
0116-0101-04Chlorhexidine Gluconate118 mL in 1 BOTTLE, PLASTICLIQUID1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0101CHLORHEXIDINE GLUCONATE LIQUID [XTTRIUM LABORATORIES, INC.]5Current NDC, Legacy NDC, 2 package rows20200327_47057d87-e142-222a-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0116-0101-0100116010101473 mL in 1 BOTTLE (0116-0101-01) 473 ml2017-06-300000-00-00NoNoCurrent
0116-0101-0400116010104118 mL in 1 BOTTLE, PLASTIC (0116-0101-04) 118 ml2016-01-220000-00-00NoNoCurrent