spironolactone

Generic: spironolactone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

spironolactone 100 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-835
Product ID 43063-835_415bbe91-c64a-e288-e063-6294a90af9cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203512
Listing Expiration 2026-12-31
Marketing Start 2017-06-02

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 43063835
Hyphenated Format 43063-835

Supplemental Identifiers

RxCUI
198222
UPC
0343063835302
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
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-90)
source: ndc

Packages (2)

43063-835-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-30) 43063-835-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-90)

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": "415bbe91-c64a-e288-e063-6294a90af9cb", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0343063835302"], "unii": ["27O7W4T232"], "rxcui": ["198222"], "spl_set_id": ["c0efa529-2870-4260-b604-2f30e2cbb87b"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-30)", "package_ndc": "43063-835-30", "marketing_start_date": "20180213"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-835-90)", "package_ndc": "43063-835-90", "marketing_start_date": "20180307"}], "brand_name": "Spironolactone", "product_id": "43063-835_415bbe91-c64a-e288-e063-6294a90af9cb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "43063-835", "generic_name": "spironolactone", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20170602", "listing_expiration_date": "20261231"}