betasept

Generic: antiseptic surgical scrub

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

Drug Facts

Product Profile

Brand Name betasept
Generic Name antiseptic surgical scrub
Labeler xttrium laboratories, inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

chlorhexidine gluconate .04 mg/mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-0200
Product ID 0116-0200_34007201-2d77-96fd-e063-6394a90a6327
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019125
Listing Expiration 2026-12-31
Marketing Start 1993-06-01

Pharmacologic Class

Classes
decreased cell wall integrity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01160200
Hyphenated Format 0116-0200

Supplemental Identifiers

RxCUI
211365 834150
UPC
0367618200087 0367618200049
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 betasept (source: ndc)
Generic Name antiseptic surgical scrub (source: ndc)
Application Number NDA019125 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .04 mg/mL
source: ndc
Packaging
  • 3785 mL in 1 BOTTLE (0116-0200-01)
  • 118 mL in 1 BOTTLE (0116-0200-04)
  • 237 mL in 1 BOTTLE (0116-0200-08)
  • 473 mL in 1 BOTTLE (0116-0200-16)
  • 946 mL in 1 BOTTLE (0116-0200-30)
  • 946 mL in 1 BOTTLE (0116-0200-32)
source: ndc

Packages (6)

0116-0200-01 3785 mL in 1 BOTTLE (0116-0200-01) 0116-0200-04 118 mL in 1 BOTTLE (0116-0200-04) 0116-0200-08 237 mL in 1 BOTTLE (0116-0200-08) 0116-0200-16 473 mL in 1 BOTTLE (0116-0200-16) 0116-0200-30 946 mL in 1 BOTTLE (0116-0200-30) 0116-0200-32 946 mL in 1 BOTTLE (0116-0200-32)

Ingredients (1)

chlorhexidine gluconate (.04 mg/mL)

Linked Drug Pages (1)

BETASEPT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "34007201-2d77-96fd-e063-6394a90a6327", "openfda": {"upc": ["0367618200087", "0367618200049"], "unii": ["MOR84MUD8E"], "rxcui": ["211365", "834150"], "spl_set_id": ["4a6451d7-b347-37ac-e054-00144ff8d46c"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3785 mL in 1 BOTTLE (0116-0200-01)", "package_ndc": "0116-0200-01", "marketing_start_date": "19930601"}, {"sample": false, "description": "118 mL in 1 BOTTLE (0116-0200-04)", "package_ndc": "0116-0200-04", "marketing_start_date": "19930601"}, {"sample": false, "description": "237 mL in 1 BOTTLE (0116-0200-08)", "package_ndc": "0116-0200-08", "marketing_start_date": "19930601"}, {"sample": false, "description": "473 mL in 1 BOTTLE (0116-0200-16)", "package_ndc": "0116-0200-16", "marketing_start_date": "19930601"}, {"sample": false, "description": "946 mL in 1 BOTTLE (0116-0200-30)", "package_ndc": "0116-0200-30", "marketing_start_date": "19930601"}, {"sample": false, "description": "946 mL in 1 BOTTLE (0116-0200-32)", "package_ndc": "0116-0200-32", "marketing_start_date": "19930601"}], "brand_name": "BETASEPT", "product_id": "0116-0200_34007201-2d77-96fd-e063-6394a90a6327", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Cell Wall Integrity [PE]"], "product_ndc": "0116-0200", "generic_name": "Antiseptic Surgical Scrub", "labeler_name": "Xttrium Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BETASEPT", "active_ingredients": [{"name": "CHLORHEXIDINE GLUCONATE", "strength": ".04 mg/mL"}], "application_number": "NDA019125", "marketing_category": "NDA", "marketing_start_date": "19930601", "listing_expiration_date": "20261231"}