calcium gluconate

Generic: calcium gluconate

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcium gluconate
Generic Name calcium gluconate
Labeler remedyrepack inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

calcium gluconate monohydrate 98 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4355
Product ID 70518-4355_37609565-10ea-35bc-e063-6394a90afc3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213071
Listing Expiration 2026-12-31
Marketing Start 2025-06-11

Pharmacologic Class

Classes
blood coagulation factor [epc] calcium [cs] cations divalent [cs] increased coagulation factor activity [pe] phosphate binder [epc] phosphate chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184355
Hyphenated Format 70518-4355

Supplemental Identifiers

RxCUI
1668250
UNII
CZN0MI5R31

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 calcium gluconate (source: ndc)
Generic Name calcium gluconate (source: ndc)
Application Number ANDA213071 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 98 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (70518-4355-0) / 10 mL in 1 VIAL (70518-4355-1)
source: ndc

Packages (1)

70518-4355-0 25 VIAL in 1 CARTON (70518-4355-0) / 10 mL in 1 VIAL (70518-4355-1)

Ingredients (1)

calcium gluconate monohydrate (98 mg/mL)

Linked Drug Pages (1)

calcium gluconate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "37609565-10ea-35bc-e063-6394a90afc3c", "openfda": {"unii": ["CZN0MI5R31"], "rxcui": ["1668250"], "spl_set_id": ["d6db3a1c-ed02-48fc-9134-ea1d58acf42e"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (70518-4355-0)  / 10 mL in 1 VIAL (70518-4355-1)", "package_ndc": "70518-4355-0", "marketing_start_date": "20250611"}], "brand_name": "calcium gluconate", "product_id": "70518-4355_37609565-10ea-35bc-e063-6394a90afc3c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Blood Coagulation Factor [EPC]", "Calcium [CS]", "Cations", "Divalent [CS]", "Increased Coagulation Factor Activity [PE]", "Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "70518-4355", "generic_name": "calcium gluconate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "calcium gluconate", "active_ingredients": [{"name": "CALCIUM GLUCONATE MONOHYDRATE", "strength": "98 mg/mL"}], "application_number": "ANDA213071", "marketing_category": "ANDA", "marketing_start_date": "20250611", "listing_expiration_date": "20261231"}