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United States · US · US:29300-468_d015993c-74da-4faa-9e51-727d6d93a867

clonidine hydrochloride

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeC02AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    2930046801
    100 TABLET in 1 BOTTLE, PLASTIC (29300-468-01)
  • ndc11
    2930046805
    500 TABLET in 1 BOTTLE, PLASTIC (29300-468-05)
  • ndc11
    2930046810
    1000 TABLET in 1 BOTTLE, PLASTIC (29300-468-10)
  • ndc11
    2930046850
    5000 TABLET in 1 BOTTLE, PLASTIC (29300-468-50)

Annotations

UNII (FDA Substance ID)
W76I6XXF06
CLONIDINE HYDROCHLORIDE
RxCUI 142432
Orange Book
A078895
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "W76I6XXF06",
    "rxcui": "142432",
    "inchikey": "ZNIFSRGNXRYGHF-UHFFFAOYSA-N",
    "display_name": "CLONIDINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ea1527a5-4939-4ff7-a827-f88a9113a07d": {
      "match": "brand_token",
      "title": "CLONIDINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "15",
      "published_date": "2026-05-28"
    }
  },
  "productid": "29300-468_d015993c-74da-4faa-9e51-727d6d93a867",
  "productndc": "29300-468",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078895",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG",
        "product_no": "001",
        "approval_date": "Aug 26, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2MG",
        "product_no": "002",
        "approval_date": "Aug 26, 2009"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3MG",
        "product_no": "003",
        "approval_date": "Aug 26, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLONIDINE HYDROCHLORIDE",
  "proprietary_name": "clonidine hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078895",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clonidine hydrochloride",
  "start_marketing_date": "20201224",
  "active_numerator_strength": ".1"
}

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