spironolactone

Generic: spironolactone

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone
Generic Name spironolactone
Labeler atlantic biologicals corp.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

spironolactone 25 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-1133
Product ID 17856-1133_3fb79d29-e4a9-4102-e063-6294a90ac064
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA209478
Listing Expiration 2026-12-31
Marketing Start 2023-10-31

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 178561133
Hyphenated Format 17856-1133

Supplemental Identifiers

RxCUI
104232
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 NDA209478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 1 SYRINGE in 1 BAG (17856-1133-1) / 2.5 mL in 1 SYRINGE
  • 1 SYRINGE in 1 BAG (17856-1133-4) / 2.5 mL in 1 SYRINGE
source: ndc

Packages (2)

17856-1133-1 1 SYRINGE in 1 BAG (17856-1133-1) / 2.5 mL in 1 SYRINGE 17856-1133-4 1 SYRINGE in 1 BAG (17856-1133-4) / 2.5 mL in 1 SYRINGE

Ingredients (1)

spironolactone (25 mg/5mL)

Linked Drug Pages (1)

SPIRONOLACTONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3fb79d29-e4a9-4102-e063-6294a90ac064", "openfda": {"nui": ["N0000175557", "N0000011310"], "unii": ["27O7W4T232"], "rxcui": ["104232"], "spl_set_id": ["122558a0-57bb-4195-9adf-d37b049cbfb5"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 BAG (17856-1133-1)  / 2.5 mL in 1 SYRINGE", "package_ndc": "17856-1133-1", "marketing_start_date": "20240603"}, {"sample": false, "description": "1 SYRINGE in 1 BAG (17856-1133-4)  / 2.5 mL in 1 SYRINGE", "package_ndc": "17856-1133-4", "marketing_start_date": "20250926"}], "brand_name": "SPIRONOLACTONE", "product_id": "17856-1133_3fb79d29-e4a9-4102-e063-6294a90ac064", "dosage_form": "SUSPENSION", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "17856-1133", "generic_name": "spironolactone", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPIRONOLACTONE", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/5mL"}], "application_number": "NDA209478", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231031", "listing_expiration_date": "20261231"}