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United States · US · US:46708-306_f2ae3ce9-d436-4616-a3eb-7838af98b9a6

clonidine hydrochloride

Orange BookUNIISPLATC C02AC01

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

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeC02AC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    4670830610
    100 TABLET in 1 CARTON (46708-306-10)
  • ndc11
    4670830630
    30 TABLET in 1 BOTTLE (46708-306-30)
  • ndc11
    4670830631
    100 TABLET in 1 BOTTLE (46708-306-31)
  • ndc11
    4670830671
    500 TABLET in 1 BOTTLE (46708-306-71)
  • ndc11
    4670830691
    1000 TABLET in 1 BOTTLE (46708-306-91)

Annotations

UNII (FDA Substance ID)
W76I6XXF06
CLONIDINE HYDROCHLORIDE
RxCUI 142432
Orange Book
A091368
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": "46708-306_f2ae3ce9-d436-4616-a3eb-7838af98b9a6",
  "productndc": "46708-306",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "091368",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG",
        "product_no": "001",
        "approval_date": "Dec 6, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2MG",
        "product_no": "002",
        "approval_date": "Dec 6, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3MG",
        "product_no": "003",
        "approval_date": "Dec 6, 2011"
      }
    ],
    "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": "ANDA091368",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clonidine Hydrochloride",
  "start_marketing_date": "20160503",
  "active_numerator_strength": ".1"
}

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