leucovorin calcium

Generic: leucovorin calcium

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

Drug Facts

Product Profile

Brand Name leucovorin calcium
Generic Name leucovorin calcium
Labeler leading pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

leucovorin calcium 5 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-184
Product ID 69315-184_f6c54ab5-7d54-4530-955d-206903b9dcad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213929
Listing Expiration 2026-12-31
Marketing Start 2020-11-16

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315184
Hyphenated Format 69315-184

Supplemental Identifiers

RxCUI
197860 197861 197862 197863
UNII
RPR1R4C0P4

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 leucovorin calcium (source: ndc)
Generic Name leucovorin calcium (source: ndc)
Application Number ANDA213929 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69315-184-01)
  • 30 TABLET in 1 BOTTLE (69315-184-03)
source: ndc

Packages (2)

69315-184-01 100 TABLET in 1 BOTTLE (69315-184-01) 69315-184-03 30 TABLET in 1 BOTTLE (69315-184-03)

Ingredients (1)

leucovorin calcium (5 mg/1)

Linked Drug Pages (1)

LEUCOVORIN CALCIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f6c54ab5-7d54-4530-955d-206903b9dcad", "openfda": {"unii": ["RPR1R4C0P4"], "rxcui": ["197860", "197861", "197862", "197863"], "spl_set_id": ["c8102043-79f2-421a-b849-94bac19007a6"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69315-184-01)", "package_ndc": "69315-184-01", "marketing_start_date": "20201116"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (69315-184-03)", "package_ndc": "69315-184-03", "marketing_start_date": "20201116"}], "brand_name": "LEUCOVORIN CALCIUM", "product_id": "69315-184_f6c54ab5-7d54-4530-955d-206903b9dcad", "dosage_form": "TABLET", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "69315-184", "generic_name": "LEUCOVORIN CALCIUM", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEUCOVORIN CALCIUM", "active_ingredients": [{"name": "LEUCOVORIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA213929", "marketing_category": "ANDA", "marketing_start_date": "20201116", "listing_expiration_date": "20261231"}