chlorhexidine gluconate

Generic: chlorhexidine gluconate

Labeler: xttrium laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorhexidine gluconate
Generic Name chlorhexidine gluconate
Labeler xttrium laboratories, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

chlorhexidine gluconate .12 mg/mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-0101
Product ID 0116-0101_a1895aa7-b2bc-dc71-e053-2995a90a2e4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077789
Listing Expiration 2026-12-31
Marketing Start 2016-01-22

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01160101
Hyphenated Format 0116-0101

Supplemental Identifiers

UNII
MOR84MUD8E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name chlorhexidine gluconate (source: ndc)
Generic Name chlorhexidine gluconate (source: ndc)
Application Number ANDA077789 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .12 mg/mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0116-0101-01)
  • 118 mL in 1 BOTTLE, PLASTIC (0116-0101-04)
source: ndc

Packages (2)

0116-0101-01 473 mL in 1 BOTTLE (0116-0101-01) 0116-0101-04 118 mL in 1 BOTTLE, PLASTIC (0116-0101-04)

Ingredients (1)

chlorhexidine gluconate (.12 mg/mL)

Linked Drug Pages (1)

Chlorhexidine Gluconate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a1895aa7-b2bc-dc71-e053-2995a90a2e4f", "openfda": {"unii": ["MOR84MUD8E"], "spl_set_id": ["47057d87-e142-222a-e054-00144ff8d46c"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0116-0101-01)", "package_ndc": "0116-0101-01", "marketing_start_date": "20170630"}, {"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (0116-0101-04)", "package_ndc": "0116-0101-04", "marketing_start_date": "20160122"}], "brand_name": "Chlorhexidine Gluconate", "product_id": "0116-0101_a1895aa7-b2bc-dc71-e053-2995a90a2e4f", "dosage_form": "LIQUID", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0116-0101", "generic_name": "Chlorhexidine Gluconate", "labeler_name": "Xttrium Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Chlorhexidine Gluconate", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": ".12 mg/mL"}], "application_number": "ANDA077789", "marketing_category": "ANDA", "marketing_start_date": "20160122", "listing_expiration_date": "20261231"}