quinidine sulfate

Generic: quinidine sulfate tablet

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quinidine sulfate
Generic Name quinidine sulfate tablet
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

quinidine sulfate 300 mg/1

Manufacturer
EPIC PHARMA, LLC

Identifiers & Regulatory

Product NDC 42806-512
Product ID 42806-512_80df716e-b0d6-4b0f-b0f4-879874d7ed05
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088072
Listing Expiration 2026-12-31
Marketing Start 2021-12-15

Pharmacologic Class

Classes
antiarrhythmic [epc] cytochrome p450 2d6 inhibitor [epc] cytochrome p450 2d6 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806512
Hyphenated Format 42806-512

Supplemental Identifiers

RxCUI
852877 852913
UPC
0342806513309 0342806512302
UNII
J13S2394HE

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 quinidine sulfate (source: ndc)
Generic Name quinidine sulfate tablet (source: ndc)
Application Number ANDA088072 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42806-512-01)
  • 30 TABLET in 1 BOTTLE (42806-512-30)
source: ndc

Packages (2)

42806-512-01 100 TABLET in 1 BOTTLE (42806-512-01) 42806-512-30 30 TABLET in 1 BOTTLE (42806-512-30)

Ingredients (1)

quinidine sulfate (300 mg/1)

Linked Drug Pages (1)

QUINIDINE SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "80df716e-b0d6-4b0f-b0f4-879874d7ed05", "openfda": {"upc": ["0342806513309", "0342806512302"], "unii": ["J13S2394HE"], "rxcui": ["852877", "852913"], "spl_set_id": ["b0d6341b-d880-4f0b-8844-bc788c03004a"], "manufacturer_name": ["EPIC PHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42806-512-01)", "package_ndc": "42806-512-01", "marketing_start_date": "20211215"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42806-512-30)", "package_ndc": "42806-512-30", "marketing_start_date": "20220102"}], "brand_name": "QUINIDINE SULFATE", "product_id": "42806-512_80df716e-b0d6-4b0f-b0f4-879874d7ed05", "dosage_form": "TABLET", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 2D6 Inhibitor [EPC]", "Cytochrome P450 2D6 Inhibitors [MoA]"], "product_ndc": "42806-512", "generic_name": "quinidine sulfate tablet", "labeler_name": "EPIC PHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "QUINIDINE SULFATE", "active_ingredients": [{"name": "QUINIDINE SULFATE", "strength": "300 mg/1"}], "application_number": "ANDA088072", "marketing_category": "ANDA", "marketing_start_date": "20211215", "listing_expiration_date": "20261231"}