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United States · US · US:0378-1903_e92f278e-0a58-49e3-8fc0-3a16b8474d3b

Midodrine Hydrochloride

Orange BookUNIISPLATC C01CA17

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC01CA17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0378190301
    100 TABLET in 1 BOTTLE, PLASTIC (0378-1903-01)

Annotations

UNII (FDA Substance ID)
59JV96YTXV
MIDODRINE HYDROCHLORIDE
RxCUI 993491
Orange Book
A076577
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": "0378-1903_e92f278e-0a58-49e3-8fc0-3a16b8474d3b",
  "productndc": "0378-1903",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076577",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Sep 10, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Sep 10, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Sep 10, 2003"
      }
    ],
    "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": "ANDA076577",
  "marketing_category": "ANDA",
  "nonproprietary_name": "midodrine hydrochloride",
  "start_marketing_date": "20030911",
  "active_numerator_strength": "10"
}

Related drugs

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