midodrine hydrochloride

Generic: midodrine hydrochloride

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midodrine hydrochloride
Generic Name midodrine hydrochloride
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

midodrine hydrochloride 2.5 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1901
Product ID 0378-1901_e92f278e-0a58-49e3-8fc0-3a16b8474d3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076577
Listing Expiration 2026-12-31
Marketing Start 2003-09-11

Pharmacologic Class

Classes
adrenergic alpha-agonists [moa] alpha-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03781901
Hyphenated Format 0378-1901

Supplemental Identifiers

RxCUI
993462 993466 993470
UNII
59JV96YTXV

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name midodrine hydrochloride (source: ndc)
Generic Name midodrine hydrochloride (source: ndc)
Application Number ANDA076577 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-1901-01)
source: ndc

Packages (1)

0378-1901-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-1901-01)

Ingredients (1)

midodrine hydrochloride (2.5 mg/1)

Linked Drug Pages (1)

Midodrine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e92f278e-0a58-49e3-8fc0-3a16b8474d3b", "openfda": {"unii": ["59JV96YTXV"], "rxcui": ["993462", "993466", "993470"], "spl_set_id": ["32fad00b-7e7b-4d35-9e8b-fdc979fdb88e"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-1901-01)", "package_ndc": "0378-1901-01", "marketing_start_date": "20030911"}], "brand_name": "Midodrine Hydrochloride", "product_id": "0378-1901_e92f278e-0a58-49e3-8fc0-3a16b8474d3b", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0378-1901", "generic_name": "midodrine hydrochloride", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midodrine Hydrochloride", "active_ingredients": [{"name": "MIDODRINE HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA076577", "marketing_category": "ANDA", "marketing_start_date": "20030911", "listing_expiration_date": "20261231"}