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 RINSE
Routes
ORAL
Active Ingredients

chlorhexidine gluconate 1.2 mg/mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-2001
Product ID 0116-2001_0cf3f53a-1fe5-92d7-e063-6394a90a9e9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077789
Listing Expiration 2026-12-31
Marketing Start 2010-06-01

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01162001
Hyphenated Format 0116-2001

Supplemental Identifiers

RxCUI
834127
UPC
0301162001158
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
  • 1.2 mg/mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (0116-2001-04)
  • 15 mL in 1 CUP, UNIT-DOSE (0116-2001-05)
  • 600 mL in 1 CASE (0116-2001-06)
  • 1500 mL in 1 CASE (0116-2001-07)
  • 15 mL in 1 BOTTLE (0116-2001-15)
  • 473 mL in 1 BOTTLE (0116-2001-16)
source: ndc

Packages (6)

0116-2001-04 118 mL in 1 BOTTLE (0116-2001-04) 0116-2001-05 15 mL in 1 CUP, UNIT-DOSE (0116-2001-05) 0116-2001-06 600 mL in 1 CASE (0116-2001-06) 0116-2001-07 1500 mL in 1 CASE (0116-2001-07) 0116-2001-15 15 mL in 1 BOTTLE (0116-2001-15) 0116-2001-16 473 mL in 1 BOTTLE (0116-2001-16)

Ingredients (1)

chlorhexidine gluconate (1.2 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": "0cf3f53a-1fe5-92d7-e063-6394a90a9e9d", "openfda": {"upc": ["0301162001158"], "unii": ["MOR84MUD8E"], "rxcui": ["834127"], "spl_set_id": ["34d15e72-8770-49dc-a514-d44ae4468a1e"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (0116-2001-04)", "package_ndc": "0116-2001-04", "marketing_start_date": "20100601"}, {"sample": false, "description": "15 mL in 1 CUP, UNIT-DOSE (0116-2001-05)", "package_ndc": "0116-2001-05", "marketing_start_date": "20210101"}, {"sample": false, "description": "600 mL in 1 CASE (0116-2001-06)", "package_ndc": "0116-2001-06", "marketing_start_date": "20210101"}, {"sample": false, "description": "1500 mL in 1 CASE (0116-2001-07)", "package_ndc": "0116-2001-07", "marketing_start_date": "20210101"}, {"sample": false, "description": "15 mL in 1 BOTTLE (0116-2001-15)", "package_ndc": "0116-2001-15", "marketing_start_date": "20100601"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0116-2001-16)", "package_ndc": "0116-2001-16", "marketing_start_date": "20100601"}], "brand_name": "Chlorhexidine Gluconate", "product_id": "0116-2001_0cf3f53a-1fe5-92d7-e063-6394a90a9e9d", "dosage_form": "RINSE", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0116-2001", "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": "1.2 mg/mL"}], "application_number": "ANDA077789", "marketing_category": "ANDA", "marketing_start_date": "20100601", "listing_expiration_date": "20261231"}