leucovorin calcium

Generic: leucovorin calcium

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

leucovorin calcium 350 mg/17.5mL

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-767
Product ID 68462-767_79d023ab-7d77-48c1-8f47-ea322fd58c2b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218200
Listing Expiration 2026-12-31
Marketing Start 2025-11-12

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462767
Hyphenated Format 68462-767

Supplemental Identifiers

RxCUI
237788
UPC
0368462767351
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 ANDA218200 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 350 mg/17.5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68462-767-35) / 17.5 mL in 1 VIAL
source: ndc

Packages (1)

68462-767-35 1 VIAL in 1 CARTON (68462-767-35) / 17.5 mL in 1 VIAL

Ingredients (1)

leucovorin calcium (350 mg/17.5mL)

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": "79d023ab-7d77-48c1-8f47-ea322fd58c2b", "openfda": {"upc": ["0368462767351"], "unii": ["RPR1R4C0P4"], "rxcui": ["237788"], "spl_set_id": ["79d023ab-7d77-48c1-8f47-ea322fd58c2b"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68462-767-35)  / 17.5 mL in 1 VIAL", "package_ndc": "68462-767-35", "marketing_start_date": "20251112"}], "brand_name": "Leucovorin Calcium", "product_id": "68462-767_79d023ab-7d77-48c1-8f47-ea322fd58c2b", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "68462-767", "generic_name": "Leucovorin Calcium", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leucovorin Calcium", "active_ingredients": [{"name": "LEUCOVORIN CALCIUM", "strength": "350 mg/17.5mL"}], "application_number": "ANDA218200", "marketing_category": "ANDA", "marketing_start_date": "20251112", "listing_expiration_date": "20261231"}