carospir

Generic: carospir

Labeler: cmp pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name carospir
Generic Name carospir
Labeler cmp pharma, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

spironolactone 25 mg/5mL

Manufacturer
CMP Pharma, Inc.

Identifiers & Regulatory

Product NDC 46287-020
Product ID 46287-020_341fea14-cdc7-4c75-b1ca-706e90dc0128
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209478
Listing Expiration 2026-12-31
Marketing Start 2017-08-04

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 46287020
Hyphenated Format 46287-020

Supplemental Identifiers

RxCUI
104232
UPC
0346287020011 0346287020042
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 carospir (source: ndc)
Generic Name carospir (source: ndc)
Application Number NDA209478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (46287-020-01)
  • 118 mL in 1 BOTTLE (46287-020-04)
  • 10 CUP, UNIT-DOSE in 1 CARTON (46287-020-50) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (3)

46287-020-01 473 mL in 1 BOTTLE (46287-020-01) 46287-020-04 118 mL in 1 BOTTLE (46287-020-04) 46287-020-50 10 CUP, UNIT-DOSE in 1 CARTON (46287-020-50) / 5 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

spironolactone (25 mg/5mL)

Linked Drug Pages (1)

CaroSpir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "341fea14-cdc7-4c75-b1ca-706e90dc0128", "openfda": {"nui": ["N0000175557", "N0000011310"], "upc": ["0346287020011", "0346287020042"], "unii": ["27O7W4T232"], "rxcui": ["104232"], "spl_set_id": ["c4f70a04-7d89-4b73-8b02-17d43471bf08"], "pharm_class_epc": ["Aldosterone Antagonist [EPC]"], "pharm_class_moa": ["Aldosterone Antagonists [MoA]"], "manufacturer_name": ["CMP Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (46287-020-01)", "package_ndc": "46287-020-01", "marketing_start_date": "20170804"}, {"sample": false, "description": "118 mL in 1 BOTTLE (46287-020-04)", "package_ndc": "46287-020-04", "marketing_start_date": "20170804"}, {"sample": false, "description": "10 CUP, UNIT-DOSE in 1 CARTON (46287-020-50)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "46287-020-50", "marketing_start_date": "20210715"}], "brand_name": "CaroSpir", "product_id": "46287-020_341fea14-cdc7-4c75-b1ca-706e90dc0128", "dosage_form": "SUSPENSION", "pharm_class": ["Aldosterone Antagonist [EPC]", "Aldosterone Antagonists [MoA]"], "product_ndc": "46287-020", "generic_name": "CaroSpir", "labeler_name": "CMP Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CaroSpir", "active_ingredients": [{"name": "SPIRONOLACTONE", "strength": "25 mg/5mL"}], "application_number": "NDA209478", "marketing_category": "NDA", "marketing_start_date": "20170804", "listing_expiration_date": "20261231"}