spironolactone

Generic: spironolactone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

spironolactone 100 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0966
Product ID 71335-0966_e0c4a6b6-aa55-4281-8c84-29e1c126c8c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091426
Listing Expiration 2026-12-31
Marketing Start 2010-08-02

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 713350966
Hyphenated Format 71335-0966

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 ANDA091426 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (71335-0966-1)
  • 3 TABLET in 1 BOTTLE (71335-0966-2)
  • 30 TABLET in 1 BOTTLE (71335-0966-3)
  • 90 TABLET in 1 BOTTLE (71335-0966-4)
  • 60 TABLET in 1 BOTTLE (71335-0966-5)
source: ndc

Packages (5)

71335-0966-1 100 TABLET in 1 BOTTLE (71335-0966-1) 71335-0966-2 3 TABLET in 1 BOTTLE (71335-0966-2) 71335-0966-3 30 TABLET in 1 BOTTLE (71335-0966-3) 71335-0966-4 90 TABLET in 1 BOTTLE (71335-0966-4) 71335-0966-5 60 TABLET in 1 BOTTLE (71335-0966-5)

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": "e0c4a6b6-aa55-4281-8c84-29e1c126c8c7", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222"], "spl_set_id": ["31aeab13-8f71-49f1-b101-8b0abb21b0dc"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-0966-1)", "package_ndc": "71335-0966-1", "marketing_start_date": "20241030"}, {"sample": false, "description": "3 TABLET in 1 BOTTLE (71335-0966-2)", "package_ndc": "71335-0966-2", "marketing_start_date": "20241030"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-0966-3)", "package_ndc": "71335-0966-3", "marketing_start_date": "20181009"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-0966-4)", "package_ndc": "71335-0966-4", "marketing_start_date": "20241030"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-0966-5)", "package_ndc": "71335-0966-5", "marketing_start_date": "20241030"}], "brand_name": "Spironolactone", "product_id": "71335-0966_e0c4a6b6-aa55-4281-8c84-29e1c126c8c7", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "71335-0966", "generic_name": "Spironolactone", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "100 mg/1"}], "application_number": "ANDA091426", "marketing_category": "ANDA", "marketing_start_date": "20100802", "listing_expiration_date": "20261231"}