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
8706318301
100 TABLET in 1 BOTTLE, PLASTIC (87063-183-01)
ndc11
8706318312
120 TABLET in 1 BOTTLE, PLASTIC (87063-183-12)
ndc11
8706318330
30 TABLET in 1 BOTTLE, PLASTIC (87063-183-30)
ndc11
8706318360
60 TABLET in 1 BOTTLE, PLASTIC (87063-183-60)
ndc11
8706318390
90 TABLET in 1 BOTTLE, PLASTIC (87063-183-90)

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": "87063-183_52424472-0f00-acac-e063-6294a90a8330",
  "productndc": "87063-183",
  "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": "20090921",
  "active_numerator_strength": ".3"
}

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