leucovorin calcium

Generic: leucovorin calcium

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leucovorin calcium
Generic Name leucovorin calcium
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

leucovorin calcium 350 mg/17.5mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-587
Product ID 68083-587_0ac32e99-c204-4104-8d83-4a24c0baccf1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218200
Listing Expiration 2026-12-31
Marketing Start 2025-11-12

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083587
Hyphenated Format 68083-587

Supplemental Identifiers

RxCUI
237788
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 ANDA218200 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/17.5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-587-01) / 17.5 mL in 1 VIAL
source: ndc

Packages (1)

68083-587-01 1 VIAL in 1 CARTON (68083-587-01) / 17.5 mL in 1 VIAL

Ingredients (1)

leucovorin calcium (350 mg/17.5mL)

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": "0ac32e99-c204-4104-8d83-4a24c0baccf1", "openfda": {"unii": ["RPR1R4C0P4"], "rxcui": ["237788"], "spl_set_id": ["968b192b-72f3-41b0-a1f5-bab8a96d3419"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-587-01)  / 17.5 mL in 1 VIAL", "package_ndc": "68083-587-01", "marketing_start_date": "20251112"}], "brand_name": "Leucovorin Calcium", "product_id": "68083-587_0ac32e99-c204-4104-8d83-4a24c0baccf1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "68083-587", "generic_name": "Leucovorin Calcium", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leucovorin Calcium", "active_ingredients": [{"name": "LEUCOVORIN CALCIUM", "strength": "350 mg/17.5mL"}], "application_number": "ANDA218200", "marketing_category": "ANDA", "marketing_start_date": "20251112", "listing_expiration_date": "20261231"}