spironolactone and hydrochlorothiazide

Generic: spironolactone and hydrochlorothiazide

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name spironolactone and hydrochlorothiazide
Generic Name spironolactone and hydrochlorothiazide
Labeler prasco laboratories
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1, spironolactone 25 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-188
Product ID 66993-188_eca75090-9808-4673-bd7e-1ecd571d3b3e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA012616
Listing Expiration 2027-12-31
Marketing Start 2021-11-29

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc] aldosterone antagonist [epc]
Mechanism of Action
aldosterone antagonists [moa]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993188
Hyphenated Format 66993-188

Supplemental Identifiers

RxCUI
198224
UPC
0366993188027
UNII
0J48LPH2TH 27O7W4T232
NUI
N0000175359 N0000175419 M0471776 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 and hydrochlorothiazide (source: ndc)
Generic Name spironolactone and hydrochlorothiazide (source: ndc)
Application Number NDA012616 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (66993-188-02)
source: ndc

Packages (1)

66993-188-02 100 TABLET, FILM COATED in 1 BOTTLE (66993-188-02)

Ingredients (2)

hydrochlorothiazide (25 mg/1) spironolactone (25 mg/1)

Linked Drug Pages (1)

Spironolactone and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eca75090-9808-4673-bd7e-1ecd571d3b3e", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000175557", "N0000011310"], "upc": ["0366993188027"], "unii": ["0J48LPH2TH", "27O7W4T232"], "rxcui": ["198224"], "spl_set_id": ["9d350fa2-d568-4970-a7a5-d128ff5d0a2f"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (66993-188-02)", "package_ndc": "66993-188-02", "marketing_start_date": "20211129"}], "brand_name": "Spironolactone and Hydrochlorothiazide", "product_id": "66993-188_eca75090-9808-4673-bd7e-1ecd571d3b3e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "66993-188", "generic_name": "spironolactone and hydrochlorothiazide", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Spironolactone and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "SPIRONOLACTONE", "strength": "25 mg/1"}], "application_number": "NDA012616", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20211129", "listing_expiration_date": "20271231"}