midodrine hydrochloride

Generic: midodrine hydrochloride

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midodrine hydrochloride
Generic Name midodrine hydrochloride
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

midodrine hydrochloride 5 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-738
Product ID 68382-738_fe679311-db62-4004-800d-2961962340de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213055
Listing Expiration 2026-12-31
Marketing Start 2020-09-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382738
Hyphenated Format 68382-738

Supplemental Identifiers

RxCUI
993462 993466 993470
UPC
0368382739018
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 ANDA213055 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-738-01)
source: ndc

Packages (1)

68382-738-01 100 TABLET in 1 BOTTLE (68382-738-01)

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": "fe679311-db62-4004-800d-2961962340de", "openfda": {"upc": ["0368382739018"], "unii": ["59JV96YTXV"], "rxcui": ["993462", "993466", "993470"], "spl_set_id": ["3bc97210-fa2f-4979-abdf-d92e5973e6e3"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-738-01)", "package_ndc": "68382-738-01", "marketing_start_date": "20200917"}], "brand_name": "Midodrine hydrochloride", "product_id": "68382-738_fe679311-db62-4004-800d-2961962340de", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "68382-738", "generic_name": "Midodrine hydrochloride", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Midodrine hydrochloride", "active_ingredients": [{"name": "MIDODRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA213055", "marketing_category": "ANDA", "marketing_start_date": "20200917", "listing_expiration_date": "20261231"}