levoleucovorin calcium

Generic: levoleucovorin injection

Labeler: hainan poly pharm. co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levoleucovorin calcium
Generic Name levoleucovorin injection
Labeler hainan poly pharm. co., ltd.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levoleucovorin calcium 10 mg/mL

Manufacturer
Hainan Poly Pharm. Co., Ltd.

Identifiers & Regulatory

Product NDC 14335-340
Product ID 14335-340_fcf83646-5cb1-2844-e053-6294a90a8a92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217314
Listing Expiration 2026-12-31
Marketing Start 2023-05-31

Pharmacologic Class

Classes
folate analog [epc] folic acid [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14335340
Hyphenated Format 14335-340

Supplemental Identifiers

RxCUI
1720765 1720773
UPC
0314335340015 0314335341012
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 calcium (source: ndc)
Generic Name levoleucovorin injection (source: ndc)
Application Number ANDA217314 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (14335-340-01) / 17.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

14335-340-01 1 VIAL, SINGLE-DOSE in 1 CARTON (14335-340-01) / 17.5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levoleucovorin calcium (10 mg/mL)

Linked Drug Pages (1)

LEVOLEUCOVORIN CALCIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fcf83646-5cb1-2844-e053-6294a90a8a92", "openfda": {"upc": ["0314335340015", "0314335341012"], "unii": ["778XL6VBS8"], "rxcui": ["1720765", "1720773"], "spl_set_id": ["c10b0c18-dd7c-4a76-a79b-b8d38a08ab87"], "manufacturer_name": ["Hainan Poly Pharm. Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (14335-340-01)  / 17.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "14335-340-01", "marketing_start_date": "20230531"}], "brand_name": "LEVOLEUCOVORIN CALCIUM", "product_id": "14335-340_fcf83646-5cb1-2844-e053-6294a90a8a92", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Folate Analog [EPC]", "Folic Acid [CS]"], "product_ndc": "14335-340", "generic_name": "levoleucovorin injection", "labeler_name": "Hainan Poly Pharm. Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOLEUCOVORIN CALCIUM", "active_ingredients": [{"name": "LEVOLEUCOVORIN CALCIUM", "strength": "10 mg/mL"}], "application_number": "ANDA217314", "marketing_category": "ANDA", "marketing_start_date": "20230531", "listing_expiration_date": "20261231"}