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United States · US · US:46708-340_38173ca4-7b7e-4c91-b12c-7cce5bfaba84

MIDODRINE HYDROCHLORIDE

Orange BookUNIISPLATC C01CA17

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

Identification

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

Packs · 2

  • ndc11
    4670834031
    100 TABLET in 1 BOTTLE (46708-340-31)
  • ndc11
    4670834071
    500 TABLET in 1 BOTTLE (46708-340-71)

Annotations

UNII (FDA Substance ID)
59JV96YTXV
MIDODRINE HYDROCHLORIDE
RxCUI 993491
Orange Book
A214734
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": "46708-340_38173ca4-7b7e-4c91-b12c-7cce5bfaba84",
  "productndc": "46708-340",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214734",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jan 21, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jan 21, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Jan 21, 2021"
      }
    ],
    "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": "ANDA214734",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MIDODRINE HYDROCHLORIDE",
  "start_marketing_date": "20210122",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C01CA17.

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