midodrine hydrochloride

Generic: midodrine hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midodrine hydrochloride
Generic Name midodrine hydrochloride
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

midodrine hydrochloride 5 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1512
Product ID 67046-1512_2d1b581e-1683-9af6-e063-6394a90ac136
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217271
Listing Expiration 2026-12-31
Marketing Start 2025-02-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461512
Hyphenated Format 67046-1512

Supplemental Identifiers

RxCUI
993470
UNII
59JV96YTXV

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 ANDA217271 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1512-3)
source: ndc

Packages (1)

67046-1512-3 30 TABLET in 1 BLISTER PACK (67046-1512-3)

Ingredients (1)

midodrine hydrochloride (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": "2d1b581e-1683-9af6-e063-6394a90ac136", "openfda": {"unii": ["59JV96YTXV"], "rxcui": ["993470"], "spl_set_id": ["2d1b58a7-ec7f-f3ea-e063-6294a90a27fb"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1512-3)", "package_ndc": "67046-1512-3", "marketing_start_date": "20250201"}], "brand_name": "Midodrine Hydrochloride", "product_id": "67046-1512_2d1b581e-1683-9af6-e063-6394a90ac136", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "67046-1512", "generic_name": "Midodrine Hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midodrine Hydrochloride", "active_ingredients": [{"name": "MIDODRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA217271", "marketing_category": "ANDA", "marketing_start_date": "20250201", "listing_expiration_date": "20261231"}