levoleucovorin

Generic: levoleucovorin

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

Drug Facts

Product Profile

Brand Name levoleucovorin
Generic Name levoleucovorin
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levoleucovorin calcium 50 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9558
Product ID 0143-9558_d5427bbc-8598-4e79-9aeb-b0a9317e3433
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206263
Listing Expiration 2026-12-31
Marketing Start 2016-07-07

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439558
Hyphenated Format 0143-9558

Supplemental Identifiers

RxCUI
1720760
UNII
778XL6VBS8

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 levoleucovorin (source: ndc)
Generic Name levoleucovorin (source: ndc)
Application Number ANDA206263 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (0143-9558-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

0143-9558-01 1 VIAL in 1 BOX (0143-9558-01) / 5 mL in 1 VIAL

Ingredients (1)

levoleucovorin calcium (50 mg/5mL)

Linked Drug Pages (1)

Levoleucovorin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d5427bbc-8598-4e79-9aeb-b0a9317e3433", "openfda": {"unii": ["778XL6VBS8"], "rxcui": ["1720760"], "spl_set_id": ["54f01988-aac2-4b0e-9d20-b7f621a0cd50"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (0143-9558-01)  / 5 mL in 1 VIAL", "package_ndc": "0143-9558-01", "marketing_start_date": "20160707"}], "brand_name": "Levoleucovorin", "product_id": "0143-9558_d5427bbc-8598-4e79-9aeb-b0a9317e3433", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "0143-9558", "generic_name": "Levoleucovorin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levoleucovorin", "active_ingredients": [{"name": "LEVOLEUCOVORIN CALCIUM", "strength": "50 mg/5mL"}], "application_number": "ANDA206263", "marketing_category": "ANDA", "marketing_start_date": "20160707", "listing_expiration_date": "20261231"}