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United States · US · US:42806-144_b84008e7-52db-4b3e-a12e-cb939852ff0f

Demeclocycline Hydrochloride

Orange BookUNIISPLATC D06AA01

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

Identification

ManufacturerEpic Pharma, LLC
CountryUS (United States)
ATC codeD06AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4280614401
    100 TABLET, FILM COATED in 1 BOTTLE (42806-144-01)
  • ndc11
    4280614430
    30 TABLET, FILM COATED in 1 BOTTLE (42806-144-30)
  • ndc11
    4280614448
    48 TABLET, FILM COATED in 1 BOTTLE (42806-144-48)

Annotations

UNII (FDA Substance ID)
29O079NTYT
DEMECLOCYCLINE HYDROCHLORIDE
RxCUI 81993
Orange Book
A065447
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "29O079NTYT",
    "rxcui": "81993",
    "inchikey": "GVSJQNRGSCOSNJ-KBHRXELFSA-N",
    "display_name": "DEMECLOCYCLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "88e03cb0-25f5-41a5-b77f-58ab8f3be181": {
      "match": "brand_token",
      "title": "DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [PURACAP LABORATORIES LLC]",
      "spl_version": "6",
      "published_date": "2025-12-12"
    }
  },
  "productid": "42806-144_b84008e7-52db-4b3e-a12e-cb939852ff0f",
  "productndc": "42806-144",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065447",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Aug 18, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEMECLOCYCLINE HYDROCHLORIDE",
  "proprietary_name": "Demeclocycline Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065447",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Demeclocycline Hydrochloride",
  "start_marketing_date": "20150202",
  "active_numerator_strength": "300"
}

Related drugs

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