leucovorin calcium

Generic: leucovorin calcium

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

Drug Facts

Product Profile

Brand Name leucovorin calcium
Generic Name leucovorin calcium
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

leucovorin calcium 500 mg/50mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-164
Product ID 71288-164_077a459b-e884-4452-aed3-0857a38ce26f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216590
Listing Expiration 2026-12-31
Marketing Start 2023-07-19

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288164
Hyphenated Format 71288-164

Supplemental Identifiers

RxCUI
237788 1803930 1803932 1803937 2055036
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
  • 500 mg/50mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-164-50) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-164-50 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-164-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

leucovorin calcium (500 mg/50mL)

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": "077a459b-e884-4452-aed3-0857a38ce26f", "openfda": {"unii": ["RPR1R4C0P4"], "rxcui": ["237788", "1803930", "1803932", "1803937", "2055036"], "spl_set_id": ["9df20901-6980-4d4e-89ec-40f3c1f91852"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-164-50)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-164-50", "marketing_start_date": "20230719"}], "brand_name": "leucovorin calcium", "product_id": "71288-164_077a459b-e884-4452-aed3-0857a38ce26f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "71288-164", "generic_name": "leucovorin calcium", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "leucovorin calcium", "active_ingredients": [{"name": "LEUCOVORIN CALCIUM", "strength": "500 mg/50mL"}], "application_number": "ANDA216590", "marketing_category": "ANDA", "marketing_start_date": "20230719", "listing_expiration_date": "20261231"}