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United States · US · US:0116-0200_34007201-2d77-96fd-e063-6394a90a6327

BETASEPT

Orange BookUNIISPLATC D08AC02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerXttrium Laboratories, Inc.
CountryUS (United States)
ATC codeD08AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    0116020001
    3785 mL in 1 BOTTLE (0116-0200-01)
  • ndc11
    0116020004
    118 mL in 1 BOTTLE (0116-0200-04)
  • ndc11
    0116020008
    237 mL in 1 BOTTLE (0116-0200-08)
  • ndc11
    0116020016
    473 mL in 1 BOTTLE (0116-0200-16)
  • ndc11
    0116020030
    946 mL in 1 BOTTLE (0116-0200-30)
  • ndc11
    0116020032
    946 mL in 1 BOTTLE (0116-0200-32)

Annotations

UNII (FDA Substance ID)
MOR84MUD8E
CHLORHEXIDINE GLUCONATE
RxCUI 20791
Orange Book
N019125
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MOR84MUD8E",
    "rxcui": "20791",
    "inchikey": "YZIYKJHYYHPJIB-UUPCJSQJSA-N",
    "display_name": "CHLORHEXIDINE GLUCONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "7e64e7bf-e88f-4056-c9e1-b49a277daa6c": {
      "match": "brand_token",
      "title": "BETASEPT (ANTISEPTIC SURGICAL SCRUB) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]",
      "spl_version": "13",
      "published_date": "2025-12-31"
    }
  },
  "productid": "0116-0200_34007201-2d77-96fd-e063-6394a90a6327",
  "productndc": "0116-0200",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "019125",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4%",
        "product_no": "001",
        "approval_date": "Dec 24, 1984"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORHEXIDINE GLUCONATE",
  "proprietary_name": "BETASEPT",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019125",
  "marketing_category": "NDA",
  "nonproprietary_name": "Antiseptic Surgical Scrub",
  "start_marketing_date": "19930601",
  "active_numerator_strength": ".04"
}

Related drugs

Other records sharing ATC code D08AC02.

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