spironolactone

Generic: spironolactone

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler zydus lifesciences limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 50 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1028
Product ID 70771-1028_038310cc-d190-4868-9442-00f7222d0597
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205936
Listing Expiration 2026-12-31
Marketing Start 2018-08-15

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 707711028
Hyphenated Format 70771-1028

Supplemental Identifiers

RxCUI
198222 198223 313096
UPC
0370771102716
UNII
27O7W4T232
NUI
N0000175557 N0000011310

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 spironolactone (source: ndc)
Generic Name spironolactone (source: ndc)
Application Number ANDA205936 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1028-0)
  • 100 TABLET, FILM COATED in 1 BOTTLE (70771-1028-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1028-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1028-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 500 TABLET, FILM COATED in 1 BOTTLE (70771-1028-5)
  • 90 TABLET, FILM COATED in 1 BOTTLE (70771-1028-9)
source: ndc

Packages (6)

70771-1028-0 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1028-0) 70771-1028-1 100 TABLET, FILM COATED in 1 BOTTLE (70771-1028-1) 70771-1028-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1028-3) 70771-1028-4 10 BLISTER PACK in 1 CARTON (70771-1028-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK 70771-1028-5 500 TABLET, FILM COATED in 1 BOTTLE (70771-1028-5) 70771-1028-9 90 TABLET, FILM COATED in 1 BOTTLE (70771-1028-9)

Ingredients (1)

spironolactone (50 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": "038310cc-d190-4868-9442-00f7222d0597", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0370771102716"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["963af399-feb7-49d2-a59c-c19edad9c682"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70771-1028-0)", "package_ndc": "70771-1028-0", "marketing_start_date": "20180815"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (70771-1028-1)", "package_ndc": "70771-1028-1", "marketing_start_date": "20180815"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1028-3)", "package_ndc": "70771-1028-3", "marketing_start_date": "20180815"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1028-4)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70771-1028-4", "marketing_start_date": "20180815"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (70771-1028-5)", "package_ndc": "70771-1028-5", "marketing_start_date": "20180815"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1028-9)", "package_ndc": "70771-1028-9", "marketing_start_date": "20180815"}], "brand_name": "spironolactone", "product_id": "70771-1028_038310cc-d190-4868-9442-00f7222d0597", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "70771-1028", "generic_name": "spironolactone", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "spironolactone", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "50 mg/1"}], "application_number": "ANDA205936", "marketing_category": "ANDA", "marketing_start_date": "20180815", "listing_expiration_date": "20261231"}