calcium gluconate

Generic: calcium gluconate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcium gluconate
Generic Name calcium gluconate
Labeler somerset therapeutics, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

calcium gluconate monohydrate 98 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-728
Product ID 70069-728_42dd49af-172b-4202-ab5c-442fa942a491
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217689
Listing Expiration 2026-12-31
Marketing Start 2023-10-20

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 70069728
Hyphenated Format 70069-728

Supplemental Identifiers

RxCUI
197435 1668248
UPC
0370069727102 0370069728017 0370069727010 0370069728109
UNII
CZN0MI5R31

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 calcium gluconate (source: ndc)
Generic Name calcium gluconate (source: ndc)
Application Number ANDA217689 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 98 mg/mL
source: ndc
Packaging
  • 10 VIAL, PLASTIC in 1 CARTON (70069-728-10) / 100 mL in 1 VIAL, PLASTIC
  • 20 VIAL, PLASTIC in 1 CARTON (70069-728-20) / 100 mL in 1 VIAL, PLASTIC (70069-728-01)
source: ndc

Packages (2)

70069-728-10 10 VIAL, PLASTIC in 1 CARTON (70069-728-10) / 100 mL in 1 VIAL, PLASTIC 70069-728-20 20 VIAL, PLASTIC in 1 CARTON (70069-728-20) / 100 mL in 1 VIAL, PLASTIC (70069-728-01)

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": "42dd49af-172b-4202-ab5c-442fa942a491", "openfda": {"upc": ["0370069727102", "0370069728017", "0370069727010", "0370069728109"], "unii": ["CZN0MI5R31"], "rxcui": ["197435", "1668248"], "spl_set_id": ["fb40eba7-04e5-40dc-8a95-5f45e7bd70bc"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, PLASTIC in 1 CARTON (70069-728-10)  / 100 mL in 1 VIAL, PLASTIC", "package_ndc": "70069-728-10", "marketing_start_date": "20240327"}, {"sample": false, "description": "20 VIAL, PLASTIC in 1 CARTON (70069-728-20)  / 100 mL in 1 VIAL, PLASTIC (70069-728-01)", "package_ndc": "70069-728-20", "marketing_start_date": "20231020"}], "brand_name": "CALCIUM GLUCONATE", "product_id": "70069-728_42dd49af-172b-4202-ab5c-442fa942a491", "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": "70069-728", "generic_name": "CALCIUM GLUCONATE", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CALCIUM GLUCONATE", "active_ingredients": [{"name": "CALCIUM GLUCONATE MONOHYDRATE", "strength": "98 mg/mL"}], "application_number": "ANDA217689", "marketing_category": "ANDA", "marketing_start_date": "20231020", "listing_expiration_date": "20261231"}