quinine sulfate

Generic: quinine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name quinine sulfate
Generic Name quinine
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

quinine sulfate 324 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-811
Product ID 65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203729
Listing Expiration 2026-12-31
Marketing Start 2016-07-29

Pharmacologic Class

Classes
antimalarial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162811
Hyphenated Format 65162-811

Supplemental Identifiers

RxCUI
997010
UNII
KF7Z0E0Q2B

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 quinine sulfate (source: ndc)
Generic Name quinine (source: ndc)
Application Number ANDA203729 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 324 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (65162-811-03)
  • 90 CAPSULE in 1 BOTTLE (65162-811-09)
  • 500 CAPSULE in 1 BOTTLE (65162-811-50)
source: ndc

Packages (3)

65162-811-03 30 CAPSULE in 1 BOTTLE (65162-811-03) 65162-811-09 90 CAPSULE in 1 BOTTLE (65162-811-09) 65162-811-50 500 CAPSULE in 1 BOTTLE (65162-811-50)

Ingredients (1)

quinine sulfate (324 mg/1)

Linked Drug Pages (1)

Quinine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b1b6d20f-5e99-4205-9f40-fa4a8af3416d", "openfda": {"unii": ["KF7Z0E0Q2B"], "rxcui": ["997010"], "spl_set_id": ["f567d5c7-ea5d-49a7-a035-b47208135f73"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65162-811-03)", "package_ndc": "65162-811-03", "marketing_start_date": "20160729"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (65162-811-09)", "package_ndc": "65162-811-09", "marketing_start_date": "20160729"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65162-811-50)", "package_ndc": "65162-811-50", "marketing_start_date": "20160729"}], "brand_name": "Quinine Sulfate", "product_id": "65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416d", "dosage_form": "CAPSULE", "pharm_class": ["Antimalarial [EPC]"], "product_ndc": "65162-811", "generic_name": "Quinine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Quinine Sulfate", "active_ingredients": [{"name": "QUININE SULFATE", "strength": "324 mg/1"}], "application_number": "ANDA203729", "marketing_category": "ANDA", "marketing_start_date": "20160729", "listing_expiration_date": "20261231"}