calcium gluconate

Generic: calcium gluconate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

calcium gluconate monohydrate 98 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9184
Product ID 0143-9184_ce7becd8-cf59-4470-aac8-82761a24ebd7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213071
Listing Expiration 2026-12-31
Marketing Start 2023-11-24

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 01439184
Hyphenated Format 0143-9184

Supplemental Identifiers

RxCUI
1668248
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 ANDA213071 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 98 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0143-9184-25) / 50 mL in 1 VIAL (0143-9184-01)
source: ndc

Packages (1)

0143-9184-25 25 VIAL in 1 CARTON (0143-9184-25) / 50 mL in 1 VIAL (0143-9184-01)

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": "ce7becd8-cf59-4470-aac8-82761a24ebd7", "openfda": {"unii": ["CZN0MI5R31"], "rxcui": ["1668248"], "spl_set_id": ["ce7becd8-cf59-4470-aac8-82761a24ebd7"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0143-9184-25)  / 50 mL in 1 VIAL (0143-9184-01)", "package_ndc": "0143-9184-25", "marketing_start_date": "20231124"}], "brand_name": "calcium gluconate", "product_id": "0143-9184_ce7becd8-cf59-4470-aac8-82761a24ebd7", "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": "0143-9184", "generic_name": "calcium gluconate", "labeler_name": "Hikma Pharmaceuticals USA 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": "20231124", "listing_expiration_date": "20261231"}