leucovorin calcium

Generic: leucovorin calcium

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leucovorin calcium
Generic Name leucovorin calcium
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

leucovorin calcium 5 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-4496
Product ID 0054-4496_4aaa6078-c6f4-49ba-98aa-a4c460126eee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072733
Listing Expiration 2026-12-31
Marketing Start 1993-02-22

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00544496
Hyphenated Format 0054-4496

Supplemental Identifiers

RxCUI
197860 197861 197862 197863
UPC
0300544499118 0300544497053 0300544498104
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 ANDA072733 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0054-4496-13)
  • 100 TABLET in 1 BOTTLE (0054-4496-25)
source: ndc

Packages (2)

0054-4496-13 30 TABLET in 1 BOTTLE (0054-4496-13) 0054-4496-25 100 TABLET in 1 BOTTLE (0054-4496-25)

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": "4aaa6078-c6f4-49ba-98aa-a4c460126eee", "openfda": {"upc": ["0300544499118", "0300544497053", "0300544498104"], "unii": ["RPR1R4C0P4"], "rxcui": ["197860", "197861", "197862", "197863"], "spl_set_id": ["33663425-4731-4977-9127-9e59b6b91497"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0054-4496-13)", "package_ndc": "0054-4496-13", "marketing_start_date": "19930222"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (0054-4496-25)", "package_ndc": "0054-4496-25", "marketing_start_date": "19930222"}], "brand_name": "Leucovorin Calcium", "product_id": "0054-4496_4aaa6078-c6f4-49ba-98aa-a4c460126eee", "dosage_form": "TABLET", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "0054-4496", "generic_name": "Leucovorin Calcium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leucovorin Calcium", "active_ingredients": [{"name": "LEUCOVORIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA072733", "marketing_category": "ANDA", "marketing_start_date": "19930222", "listing_expiration_date": "20261231"}