leucovorin calcium

Generic: leucovorin calcium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leucovorin calcium
Generic Name leucovorin calcium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

leucovorin calcium 500 mg/50mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-711
Product ID 63323-711_2497bd71-0f85-48ec-9353-d591e1c728f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040286
Listing Expiration 2026-12-31
Marketing Start 2010-09-18

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323711
Hyphenated Format 63323-711

Supplemental Identifiers

RxCUI
1803937 2055036
UPC
0363323711009 0363323710507
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 ANDA040286 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/50mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (63323-711-00) / 50 mL in 1 VIAL
source: ndc

Packages (1)

63323-711-00 1 VIAL in 1 BOX (63323-711-00) / 50 mL in 1 VIAL

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": "2497bd71-0f85-48ec-9353-d591e1c728f8", "openfda": {"upc": ["0363323711009", "0363323710507"], "unii": ["RPR1R4C0P4"], "rxcui": ["1803937", "2055036"], "spl_set_id": ["e3b957dc-a542-4f69-b8a0-7df401ee706f"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (63323-711-00)  / 50 mL in 1 VIAL", "package_ndc": "63323-711-00", "marketing_start_date": "20100918"}], "brand_name": "Leucovorin Calcium", "product_id": "63323-711_2497bd71-0f85-48ec-9353-d591e1c728f8", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "63323-711", "generic_name": "LEUCOVORIN CALCIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leucovorin Calcium", "active_ingredients": [{"name": "LEUCOVORIN CALCIUM", "strength": "500 mg/50mL"}], "application_number": "ANDA040286", "marketing_category": "ANDA", "marketing_start_date": "20100918", "listing_expiration_date": "20261231"}