clonidine hydrochloride

Orange BookUNIISPLATC C02AC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeC02AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7642006601
100 TABLET in 1 BOTTLE (76420-066-01)
ndc11
7642006620
20 TABLET in 1 BOTTLE (76420-066-20)
ndc11
7642006630
30 TABLET in 1 BOTTLE (76420-066-30)
ndc11
7642006660
60 TABLET in 1 BOTTLE (76420-066-60)
ndc11
7642006690
90 TABLET in 1 BOTTLE (76420-066-90)

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": "76420-066_b26a7261-c68e-834b-e053-2a95a90a1f7d",
  "productndc": "76420-066",
  "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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