midodrine hydrochloride

Generic: midodrine hydrochloride

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name midodrine hydrochloride
Generic Name midodrine hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

midodrine hydrochloride 2.5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-338
Product ID 46708-338_38173ca4-7b7e-4c91-b12c-7cce5bfaba84
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214734
Listing Expiration 2026-12-31
Marketing Start 2021-01-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708338
Hyphenated Format 46708-338

Supplemental Identifiers

RxCUI
993462 993466 993470
UPC
0346708339319 0346708340315 0346708338312
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 ANDA214734 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (46708-338-31)
  • 500 TABLET in 1 BOTTLE (46708-338-71)
source: ndc

Packages (2)

46708-338-31 100 TABLET in 1 BOTTLE (46708-338-31) 46708-338-71 500 TABLET in 1 BOTTLE (46708-338-71)

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": "38173ca4-7b7e-4c91-b12c-7cce5bfaba84", "openfda": {"upc": ["0346708339319", "0346708340315", "0346708338312"], "unii": ["59JV96YTXV"], "rxcui": ["993462", "993466", "993470"], "spl_set_id": ["03b54024-2a26-4abe-bd8b-b66bb6781fa7"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-338-31)", "package_ndc": "46708-338-31", "marketing_start_date": "20210122"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (46708-338-71)", "package_ndc": "46708-338-71", "marketing_start_date": "20210122"}], "brand_name": "MIDODRINE HYDROCHLORIDE", "product_id": "46708-338_38173ca4-7b7e-4c91-b12c-7cce5bfaba84", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha-Agonists [MoA]", "alpha-Adrenergic Agonist [EPC]"], "product_ndc": "46708-338", "generic_name": "MIDODRINE HYDROCHLORIDE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MIDODRINE HYDROCHLORIDE", "active_ingredients": [{"name": "MIDODRINE HYDROCHLORIDE", "strength": "2.5 mg/1"}], "application_number": "ANDA214734", "marketing_category": "ANDA", "marketing_start_date": "20210122", "listing_expiration_date": "20261231"}