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United States · US · US:60687-705_230a18ee-ef80-61c6-e063-6394a90acb5d

Demeclocycline Hydrochloride

Orange BookUNIISPLATC D06AA01

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeD06AA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068770565
    50 BLISTER PACK in 1 CARTON (60687-705-65) / 1 TABLET in 1 BLISTER PACK (60687-705-11)

Annotations

UNII (FDA Substance ID)
29O079NTYT
DEMECLOCYCLINE HYDROCHLORIDE
RxCUI 81993
Orange Book
A065425
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": "60687-705_230a18ee-ef80-61c6-e063-6394a90acb5d",
  "productndc": "60687-705",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "065425",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Feb 27, 2008"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Feb 27, 2008"
      }
    ],
    "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": "ANDA065425",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Demeclocycline",
  "start_marketing_date": "20230119",
  "active_numerator_strength": "300"
}

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