Midodrine Hydrochloride

Orange BookUNIISPLATC C01CA17

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

Identification

ManufacturerUpsher-Smith laboratories, LLC

CountryUS (United States)

ATC codeC01CA17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0245021101
100 BLISTER PACK in 1 CARTON (0245-0211-01) / 1 TABLET in 1 BLISTER PACK (0245-0211-89)
ndc11
0245021111
100 TABLET in 1 BOTTLE (0245-0211-11)

Annotations

UNII (FDA Substance ID)

59JV96YTXV

MIDODRINE HYDROCHLORIDE

RxCUI 993491

Orange Book

A076725

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "59JV96YTXV",
    "rxcui": "993491",
    "inchikey": "MGCQZNBCJBRZDT-UHFFFAOYSA-N",
    "display_name": "MIDODRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4d5e42be-3476-85d4-e063-6294a90a0865": {
      "match": "brand_token",
      "title": "MIDODRINE HYDROCHLORIDE TABLET [AVET PHARMACEUTICALS INC.]",
      "spl_version": "1",
      "published_date": "2026-03-27"
    }
  },
  "productid": "0245-0211_18b0b9f5-6026-479e-af12-92b0e71a9d6b",
  "productndc": "0245-0211",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076725",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Nov 3, 2004"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Nov 3, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Nov 3, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MIDODRINE HYDROCHLORIDE",
  "proprietary_name": "Midodrine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076725",
  "marketing_category": "ANDA",
  "nonproprietary_name": "midodrine hydrochloride",
  "start_marketing_date": "20041103",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code C01CA17.

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