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United States · US · US:31722-504_fbbb1836-2fa8-f7a6-e053-6394a90a8718

Efavirenz

Orange BookUNIISPLATC J05AG03

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ05AG03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3172250425
    250 TABLET, FILM COATED in 1 BOTTLE (31722-504-25)
  • ndc11
    3172250430
    30 TABLET, FILM COATED in 1 BOTTLE (31722-504-30)

Annotations

UNII (FDA Substance ID)
JE6H2O27P8
EFAVIRENZ
RxCUI 195085
Orange Book
A078886
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "JE6H2O27P8",
    "rxcui": "195085",
    "inchikey": "XPOQHMRABVBWPR-ZDUSSCGKSA-N",
    "display_name": "EFAVIRENZ",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "92603fa5-7a2c-4bfb-9a70-aadb4fba952c": {
      "match": "brand_token",
      "title": "EFAVIRENZ TABLET, FILM COATED [CIPLA USA INC.]",
      "spl_version": "7",
      "published_date": "2024-09-10"
    }
  },
  "productid": "31722-504_fbbb1836-2fa8-f7a6-e053-6394a90a8718",
  "productndc": "31722-504",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078886",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Apr 27, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EFAVIRENZ",
  "proprietary_name": "Efavirenz",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078886",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Efavirenz",
  "start_marketing_date": "20180427",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code J05AG03.

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