midodrine hydrochloride

Generic: midodrine hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midodrine hydrochloride
Generic Name midodrine hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

midodrine hydrochloride 10 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8384
Product ID 0615-8384_8970ba1c-ea60-4d30-be3b-e53b1bdc7871
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212774
Listing Expiration 2026-12-31
Marketing Start 2020-08-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158384
Hyphenated Format 0615-8384

Supplemental Identifiers

RxCUI
993462 993466 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 ANDA212774 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BLISTER PACK (0615-8384-05)
  • 30 TABLET in 1 BLISTER PACK (0615-8384-39)
source: ndc

Packages (2)

0615-8384-05 15 TABLET in 1 BLISTER PACK (0615-8384-05) 0615-8384-39 30 TABLET in 1 BLISTER PACK (0615-8384-39)

Ingredients (1)

midodrine hydrochloride (10 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": "8970ba1c-ea60-4d30-be3b-e53b1bdc7871", "openfda": {"unii": ["59JV96YTXV"], "rxcui": ["993462", "993466", "993470"], "spl_set_id": ["6c089bcf-c3ac-44c3-9336-8358c4d81bcd"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BLISTER PACK (0615-8384-05)", "package_ndc": "0615-8384-05", "marketing_start_date": "20240911"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8384-39)", "package_ndc": "0615-8384-39", "marketing_start_date": "20210204"}], "brand_name": "Midodrine Hydrochloride", "product_id": "0615-8384_8970ba1c-ea60-4d30-be3b-e53b1bdc7871", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "0615-8384", "generic_name": "Midodrine Hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midodrine Hydrochloride", "active_ingredients": [{"name": "MIDODRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA212774", "marketing_category": "ANDA", "marketing_start_date": "20200810", "listing_expiration_date": "20261231"}