levoleucovorin (71288-104)

Drug Facts

Product Profile

Brand Name levoleucovorin

Generic Name levoleucovorin calcium

Labeler meitheal pharmaceuticals inc

Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

levoleucovorin calcium 50 mg/5mL

Manufacturer

Meitheal Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 71288-104

Product ID 71288-104_a0d839ca-80eb-4061-a0c4-30e5d94af094

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA211003

Listing Expiration 2026-12-31

Marketing Start 2019-08-22

Pharmacologic Class

Classes

folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288104

Hyphenated Format 71288-104

Supplemental Identifiers

RxCUI

1720760

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 ANDA211003 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

50 mg/5mL

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING Levoleucovorin for Injection is a sterile white to pale yellow lyophilized powder or lyophilized cake, and is supplied as follows: NDC Levoleucovorin for Injection Package Factor 71288- 104 -10 50 mg Single-Dose Vial 1 vial per carton Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Store in carton until contents are used. Discard unused portion. Lyophilized. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2020 Meitheal Pharmaceuticals Inc. Revised: December 2020
Principal Display Panel – Levoleucovorin for Injection 50 mg Vial Label NDC 71288- 104 -10 Rx only Levoleucovorin for Injection 50 mg per vial present as levoleucovorin calcium Lyophilized Single-Dose Vial Discard unused portion For Intravenous Use Principal Display Panel – Levoleucovorin for Injection 50 mg Vial Label
Principal Display Panel – Levoleucovorin for Injection 50 mg Carton NDC 71288- 104 -10 Levoleucovorin for Injection 50 mg per vial present as levoleucovorin calcium Lyophilized 1 Single-Dose Vial Discard unused portion For Intravenous Use Principal Display Panel – Levoleucovorin for Injection 50 mg Carton

source: label

Packages (0)

No package records.

Ingredients (1)

levoleucovorin calcium (50 mg/5mL)

Linked Drug Pages (1)

Levoleucovorin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "a0d839ca-80eb-4061-a0c4-30e5d94af094", "openfda": {"unii": ["778XL6VBS8"], "rxcui": ["1720760"], "spl_set_id": ["b4dd0e14-d42a-4581-b1f0-7ba95b50bca6"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Levoleucovorin", "product_id": "71288-104_a0d839ca-80eb-4061-a0c4-30e5d94af094", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "71288-104", "generic_name": "levoleucovorin calcium", "labeler_name": "Meitheal Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levoleucovorin", "active_ingredients": [{"name": "LEVOLEUCOVORIN CALCIUM", "strength": "50 mg/5mL"}], "application_number": "ANDA211003", "marketing_category": "ANDA", "marketing_start_date": "20190822", "listing_expiration_date": "20261231"}