levoleucovorin

Generic: levoleucovorin

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levoleucovorin
Generic Name levoleucovorin
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levoleucovorin calcium 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-279
Product ID 68083-279_c3b9daf5-c553-46af-b651-841b43b2e706
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210892
Listing Expiration 2026-12-31
Marketing Start 2018-09-20

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083279
Hyphenated Format 68083-279

Supplemental Identifiers

RxCUI
1720765
UPC
0368083278014
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 (source: ndc)
Application Number ANDA210892 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-279-01) / 25 mL in 1 VIAL
source: ndc

Packages (1)

68083-279-01 1 VIAL in 1 CARTON (68083-279-01) / 25 mL in 1 VIAL

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": "c3b9daf5-c553-46af-b651-841b43b2e706", "openfda": {"upc": ["0368083278014"], "unii": ["778XL6VBS8"], "rxcui": ["1720765"], "spl_set_id": ["dbb3613c-78a9-4a96-a766-17e7a9e8809b"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-279-01)  / 25 mL in 1 VIAL", "package_ndc": "68083-279-01", "marketing_start_date": "20180920"}], "brand_name": "levoleucovorin", "product_id": "68083-279_c3b9daf5-c553-46af-b651-841b43b2e706", "dosage_form": "INJECTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "68083-279", "generic_name": "Levoleucovorin", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levoleucovorin", "active_ingredients": [{"name": "LEVOLEUCOVORIN CALCIUM", "strength": "10 mg/mL"}], "application_number": "ANDA210892", "marketing_category": "ANDA", "marketing_start_date": "20180920", "listing_expiration_date": "20261231"}