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
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

leucovorin calcium 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-631
Product ID 63323-631_d1c72e5d-c25e-4b9c-b3dc-a8d0b746db3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207241
Listing Expiration 2026-12-31
Marketing Start 2017-01-31

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323631
Hyphenated Format 63323-631

Supplemental Identifiers

RxCUI
2099993 2104714
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 ANDA207241 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (63323-631-10) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

63323-631-10 1 VIAL, SINGLE-USE in 1 CARTON (63323-631-10) / 10 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

leucovorin calcium (10 mg/mL)

Linked Drug Pages (2)

Leucovorin calcium ndc-match (0.9) Leucovorin calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "d1c72e5d-c25e-4b9c-b3dc-a8d0b746db3f", "openfda": {"unii": ["RPR1R4C0P4"], "rxcui": ["2099993", "2104714"], "spl_set_id": ["d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (63323-631-10)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "63323-631-10", "marketing_start_date": "20170131"}], "brand_name": "Leucovorin calcium", "product_id": "63323-631_d1c72e5d-c25e-4b9c-b3dc-a8d0b746db3f", "dosage_form": "INJECTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "63323-631", "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": "10 mg/mL"}], "application_number": "ANDA207241", "marketing_category": "ANDA", "marketing_start_date": "20170131", "listing_expiration_date": "20261231"}