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
Routes
INTRAVENOUS
Active Ingredients

calcium gluconate monohydrate 98 mg/mL

Manufacturer
Amneal Pharmaceuticals Private Limited

Identifiers & Regulatory

Product NDC 80830-1673
Product ID 80830-1673_eefdd45b-6407-4e69-b285-cd5b09d8dbdd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216611
Listing Expiration 2026-12-31
Marketing Start 2024-05-13

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 808301673
Hyphenated Format 80830-1673

Supplemental Identifiers

RxCUI
197435 1668250
UPC
0380830167310 0380830167211 0380830167488 0380830167358
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 ANDA216611 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 98 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (80830-1673-2) / 50 mL in 1 VIAL (80830-1673-1)
  • 25 VIAL in 1 CARTON (80830-1673-5) / 50 mL in 1 VIAL (80830-1673-1)
source: ndc

Packages (2)

80830-1673-2 10 VIAL in 1 CARTON (80830-1673-2) / 50 mL in 1 VIAL (80830-1673-1) 80830-1673-5 25 VIAL in 1 CARTON (80830-1673-5) / 50 mL in 1 VIAL (80830-1673-1)

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": "eefdd45b-6407-4e69-b285-cd5b09d8dbdd", "openfda": {"upc": ["0380830167310", "0380830167211", "0380830167488", "0380830167358"], "unii": ["CZN0MI5R31"], "rxcui": ["197435", "1668250"], "spl_set_id": ["13d7cfc9-ff7a-437e-8c21-d9709ac07d48"], "manufacturer_name": ["Amneal Pharmaceuticals Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (80830-1673-2)  / 50 mL in 1 VIAL (80830-1673-1)", "package_ndc": "80830-1673-2", "marketing_start_date": "20240513"}, {"sample": false, "description": "25 VIAL in 1 CARTON (80830-1673-5)  / 50 mL in 1 VIAL (80830-1673-1)", "package_ndc": "80830-1673-5", "marketing_start_date": "20240513"}], "brand_name": "calcium gluconate", "product_id": "80830-1673_eefdd45b-6407-4e69-b285-cd5b09d8dbdd", "dosage_form": "INJECTION", "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": "80830-1673", "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": "98 mg/mL"}], "application_number": "ANDA216611", "marketing_category": "ANDA", "marketing_start_date": "20240513", "listing_expiration_date": "20261231"}