chlorhexidine gluconate

Generic: chlorhexidine gluconate

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name chlorhexidine gluconate
Generic Name chlorhexidine gluconate
Labeler pai holdings, llc dba pai pharma
Dosage Form RINSE
Routes
ORAL
Active Ingredients

chlorhexidine gluconate 1.2 mg/mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0893
Product ID 0121-0893_0b2578ba-9a50-4316-a225-196ff2fac285
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074522
Listing Expiration 2026-12-31
Marketing Start 1995-12-15

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210893
Hyphenated Format 0121-0893

Supplemental Identifiers

RxCUI
834127
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 ANDA074522 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.2 mg/mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-0893-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15)
  • 473 mL in 1 BOTTLE (0121-0893-16)
  • 4 TRAY in 1 CASE (0121-0893-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15)
source: ndc

Packages (3)

0121-0893-00 10 TRAY in 1 CASE (0121-0893-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15) 0121-0893-16 473 mL in 1 BOTTLE (0121-0893-16) 0121-0893-40 4 TRAY in 1 CASE (0121-0893-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15)

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": "0b2578ba-9a50-4316-a225-196ff2fac285", "openfda": {"unii": ["MOR84MUD8E"], "rxcui": ["834127"], "spl_set_id": ["d3c2d8a7-bad5-410f-af83-e78a45e4b93f"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-0893-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15)", "package_ndc": "0121-0893-00", "marketing_start_date": "20200918"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0121-0893-16)", "package_ndc": "0121-0893-16", "marketing_start_date": "20200918"}, {"sample": false, "description": "4 TRAY in 1 CASE (0121-0893-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-0893-15)", "package_ndc": "0121-0893-40", "marketing_start_date": "20200918"}], "brand_name": "CHLORHEXIDINE GLUCONATE", "product_id": "0121-0893_0b2578ba-9a50-4316-a225-196ff2fac285", "dosage_form": "RINSE", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0121-0893", "generic_name": "CHLORHEXIDINE GLUCONATE", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CHLORHEXIDINE GLUCONATE", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": "1.2 mg/mL"}], "application_number": "ANDA074522", "marketing_category": "ANDA", "marketing_start_date": "19951215", "listing_expiration_date": "20261231"}