calcium gluconate

Generic: calcium gluconate

Labeler: amneal pharmaceuticals private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name calcium gluconate
Generic Name calcium gluconate
Labeler amneal pharmaceuticals private limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

calcium gluconate monohydrate 20 mg/mL

Manufacturer
Amneal Pharmaceuticals Private Limited

Identifiers & Regulatory

Product NDC 80830-2363
Product ID 80830-2363_2bd614b6-02ce-49e3-86e2-dfaec7a13e04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217174
Listing Expiration 2026-12-31
Marketing Start 2023-09-08

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 808302363
Hyphenated Format 80830-2363

Supplemental Identifiers

RxCUI
2117608 2117610
UPC
0380830236290
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 ANDA217174 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (80830-2363-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
  • 24 POUCH in 1 CARTON (80830-2363-9) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
source: ndc

Packages (2)

80830-2363-2 12 POUCH in 1 CARTON (80830-2363-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG 80830-2363-9 24 POUCH in 1 CARTON (80830-2363-9) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Ingredients (1)

calcium gluconate monohydrate (20 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": "2bd614b6-02ce-49e3-86e2-dfaec7a13e04", "openfda": {"upc": ["0380830236290"], "unii": ["CZN0MI5R31"], "rxcui": ["2117608", "2117610"], "spl_set_id": ["8ee79b4c-21d3-4742-ae37-e2f562917706"], "manufacturer_name": ["Amneal Pharmaceuticals Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (80830-2363-2)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "80830-2363-2", "marketing_start_date": "20231108"}, {"sample": false, "description": "24 POUCH in 1 CARTON (80830-2363-9)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "80830-2363-9", "marketing_start_date": "20230908"}], "brand_name": "CALCIUM GLUCONATE", "product_id": "80830-2363_2bd614b6-02ce-49e3-86e2-dfaec7a13e04", "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": "80830-2363", "generic_name": "calcium gluconate", "labeler_name": "Amneal Pharmaceuticals Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CALCIUM GLUCONATE", "active_ingredients": [{"name": "CALCIUM GLUCONATE MONOHYDRATE", "strength": "20 mg/mL"}], "application_number": "ANDA217174", "marketing_category": "ANDA", "marketing_start_date": "20230908", "listing_expiration_date": "20261231"}