leucovorin calcium

Generic: leucovorin calcium

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leucovorin calcium
Generic Name leucovorin calcium
Labeler bluepoint laboratories
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

leucovorin calcium 100 mg/10mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-648
Product ID 68001-648_3ff11eb8-de81-1e0d-e063-6394a90a0f7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216590
Listing Expiration 2026-12-31
Marketing Start 2025-05-10

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001648
Hyphenated Format 68001-648

Supplemental Identifiers

RxCUI
237788 1803932 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 ANDA216590 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-648-36) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68001-648-36 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-648-36) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

leucovorin calcium (100 mg/10mL)

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": "3ff11eb8-de81-1e0d-e063-6394a90a0f7c", "openfda": {"unii": ["RPR1R4C0P4"], "rxcui": ["237788", "1803932", "1803937"], "spl_set_id": ["f579879c-7d53-4663-8ad8-84b8b645cda5"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68001-648-36)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68001-648-36", "marketing_start_date": "20250814"}], "brand_name": "leucovorin calcium", "product_id": "68001-648_3ff11eb8-de81-1e0d-e063-6394a90a0f7c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "68001-648", "generic_name": "leucovorin calcium", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "leucovorin calcium", "active_ingredients": [{"name": "LEUCOVORIN CALCIUM", "strength": "100 mg/10mL"}], "application_number": "ANDA216590", "marketing_category": "ANDA", "marketing_start_date": "20250510", "listing_expiration_date": "20261231"}