spironolactone

Generic: spironolactone

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

spironolactone 25 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 72603-134
Product ID 72603-134_04da3e98-02e5-4d5a-94b2-9a6f74c44f15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202187
Listing Expiration 2027-12-31
Marketing Start 2019-12-13

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 72603134
Hyphenated Format 72603-134

Supplemental Identifiers

RxCUI
198222 198223 313096
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 ANDA202187 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72603-134-01)
  • 500 TABLET in 1 BOTTLE (72603-134-02)
  • 1000 TABLET in 1 BOTTLE (72603-134-03)
source: ndc

Packages (3)

72603-134-01 100 TABLET in 1 BOTTLE (72603-134-01) 72603-134-02 500 TABLET in 1 BOTTLE (72603-134-02) 72603-134-03 1000 TABLET in 1 BOTTLE (72603-134-03)

Ingredients (1)

spironolactone (25 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": "04da3e98-02e5-4d5a-94b2-9a6f74c44f15", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["198222", "198223", "313096"], "spl_set_id": ["ae0dcb4e-63df-459c-8e60-0caa817b8135"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72603-134-01)", "package_ndc": "72603-134-01", "marketing_start_date": "20191213"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72603-134-02)", "package_ndc": "72603-134-02", "marketing_start_date": "20191213"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (72603-134-03)", "package_ndc": "72603-134-03", "marketing_start_date": "20191213"}], "brand_name": "SPIRONOLACTONE", "product_id": "72603-134_04da3e98-02e5-4d5a-94b2-9a6f74c44f15", "dosage_form": "TABLET", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "72603-134", "generic_name": "SPIRONOLACTONE", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPIRONOLACTONE", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "ANDA202187", "marketing_category": "ANDA", "marketing_start_date": "20191213", "listing_expiration_date": "20271231"}