spironolactone

Generic: spironolactone

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 100 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-344
Product ID 51655-344_48eb2ef1-10f5-aa75-e063-6294a90a901f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203512
Listing Expiration 2027-12-31
Marketing Start 2020-05-27

Pharmacologic Class

Established (EPC)
aldosterone antagonist [epc]
Mechanism of Action
aldosterone antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655344
Hyphenated Format 51655-344

Supplemental Identifiers

RxCUI
198222
UNII
27O7W4T232
NUI
N0000175557 N0000011310

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 spironolactone (source: ndc)
Generic Name spironolactone (source: ndc)
Application Number ANDA203512 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (51655-344-26)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-344-52)
source: ndc

Packages (2)

51655-344-26 90 TABLET, FILM COATED in 1 BOTTLE (51655-344-26) 51655-344-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-344-52)

Ingredients (1)

spironolactone (100 mg/1)

Linked Drug Pages (1)

Spironolactone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48eb2ef1-10f5-aa75-e063-6294a90a901f", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222"], "spl_set_id": ["ab3090fc-458c-17c1-e053-2995a90a6ffa"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (51655-344-26)", "package_ndc": "51655-344-26", "marketing_start_date": "20200527"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-344-52)", "package_ndc": "51655-344-52", "marketing_start_date": "20200824"}], "brand_name": "Spironolactone", "product_id": "51655-344_48eb2ef1-10f5-aa75-e063-6294a90a901f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "51655-344", "generic_name": "spironolactone", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA203512", "marketing_category": "ANDA", "marketing_start_date": "20200527", "listing_expiration_date": "20271231"}