leucovorin calcium

Generic: leucovorin calcium

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leucovorin calcium
Generic Name leucovorin calcium
Labeler mylan institutional llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

leucovorin calcium 350 mg/17.5mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-530
Product ID 67457-530_2890b03c-dbef-4db8-8b07-c042d7765677
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203800
Listing Expiration 2026-12-31
Marketing Start 2019-01-02

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457530
Hyphenated Format 67457-530

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 ANDA203800 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/17.5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-530-35) / 17.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

67457-530-35 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-530-35) / 17.5 mL in 1 VIAL, SINGLE-DOSE

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": "2890b03c-dbef-4db8-8b07-c042d7765677", "openfda": {"unii": ["RPR1R4C0P4"], "rxcui": ["237788", "1803932", "1803937"], "spl_set_id": ["1cb701ca-2478-4268-9d69-80293965d59d"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-530-35)  / 17.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67457-530-35", "marketing_start_date": "20190102"}], "brand_name": "LEUCOVORIN CALCIUM", "product_id": "67457-530_2890b03c-dbef-4db8-8b07-c042d7765677", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "67457-530", "generic_name": "LEUCOVORIN CALCIUM", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEUCOVORIN CALCIUM", "active_ingredients": [{"name": "LEUCOVORIN CALCIUM", "strength": "350 mg/17.5mL"}], "application_number": "ANDA203800", "marketing_category": "ANDA", "marketing_start_date": "20190102", "listing_expiration_date": "20261231"}