levoleucovorin

Generic: levoleucovorin calcium

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

Drug Facts

Product Profile

Brand Name levoleucovorin
Generic Name levoleucovorin calcium
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levoleucovorin calcium 10 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-105
Product ID 71288-105_17100790-fb82-43cd-80eb-b3e73d918bbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211002
Listing Expiration 2026-12-31
Marketing Start 2019-08-16

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288105
Hyphenated Format 71288-105

Supplemental Identifiers

RxCUI
1720765 1720773
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 calcium (source: ndc)
Application Number ANDA211002 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-18) / 17.5 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25) / 25 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

71288-105-18 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-18) / 17.5 mL in 1 VIAL, SINGLE-DOSE 71288-105-25 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25) / 25 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levoleucovorin calcium (10 mg/mL)

Linked Drug Pages (1)

Levoleucovorin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "17100790-fb82-43cd-80eb-b3e73d918bbd", "openfda": {"unii": ["778XL6VBS8"], "rxcui": ["1720765", "1720773"], "spl_set_id": ["059a3306-6207-497f-a947-33198f18761f"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-18)  / 17.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-105-18", "marketing_start_date": "20190816"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25)  / 25 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-105-25", "marketing_start_date": "20190816"}], "brand_name": "Levoleucovorin", "product_id": "71288-105_17100790-fb82-43cd-80eb-b3e73d918bbd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "71288-105", "generic_name": "levoleucovorin calcium", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levoleucovorin", "active_ingredients": [{"name": "LEVOLEUCOVORIN CALCIUM", "strength": "10 mg/mL"}], "application_number": "ANDA211002", "marketing_category": "ANDA", "marketing_start_date": "20190816", "listing_expiration_date": "20261231"}