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 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

leucovorin calcium 200 mg/20mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9368
Product ID 0143-9368_0000f768-a8cc-46ba-95a1-88b0ebd09be7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040056
Listing Expiration 2026-12-31
Marketing Start 1995-05-23

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439368
Hyphenated Format 0143-9368

Supplemental Identifiers

RxCUI
1803937
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 ANDA040056 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/20mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX, UNIT-DOSE (0143-9368-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

0143-9368-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9368-01) / 20 mL in 1 VIAL

Ingredients (1)

leucovorin calcium (200 mg/20mL)

Linked Drug Pages (1)

Leucovorin Calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "0000f768-a8cc-46ba-95a1-88b0ebd09be7", "openfda": {"unii": ["RPR1R4C0P4"], "rxcui": ["1803937"], "spl_set_id": ["f198ab39-9394-4280-be44-93a88264a450"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9368-01)  / 20 mL in 1 VIAL", "package_ndc": "0143-9368-01", "marketing_start_date": "20191001"}], "brand_name": "Leucovorin Calcium", "product_id": "0143-9368_0000f768-a8cc-46ba-95a1-88b0ebd09be7", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "0143-9368", "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": "200 mg/20mL"}], "application_number": "ANDA040056", "marketing_category": "ANDA", "marketing_start_date": "19950523", "listing_expiration_date": "20261231"}