calcium gluconate

Generic: calcium gluconate

Labeler: b. braun medical inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

calcium gluconate monohydrate 98 mg/mL

Manufacturer
B. Braun Medical Inc.

Identifiers & Regulatory

Product NDC 0264-5600
Product ID 0264-5600_c39effaa-a9b8-4430-a42a-c642b76550df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216541
Listing Expiration 2026-12-31
Marketing Start 2023-11-02

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 02645600
Hyphenated Format 0264-5600

Supplemental Identifiers

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 ANDA216541 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 98 mg/mL
source: ndc
Packaging
  • 24 CONTAINER in 1 CASE (0264-5600-52) / 100 mL in 1 CONTAINER
source: ndc

Packages (1)

0264-5600-52 24 CONTAINER in 1 CASE (0264-5600-52) / 100 mL in 1 CONTAINER

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": "c39effaa-a9b8-4430-a42a-c642b76550df", "openfda": {"unii": ["CZN0MI5R31"], "spl_set_id": ["af362bcb-7010-4eb5-b8c4-42aa3b0cdcde"], "manufacturer_name": ["B. Braun Medical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 CONTAINER in 1 CASE (0264-5600-52)  / 100 mL in 1 CONTAINER", "package_ndc": "0264-5600-52", "marketing_start_date": "20231102"}], "brand_name": "Calcium Gluconate", "product_id": "0264-5600_c39effaa-a9b8-4430-a42a-c642b76550df", "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": "0264-5600", "generic_name": "Calcium Gluconate", "labeler_name": "B. Braun Medical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Calcium Gluconate", "active_ingredients": [{"name": "CALCIUM GLUCONATE MONOHYDRATE", "strength": "98 mg/mL"}], "application_number": "ANDA216541", "marketing_category": "ANDA", "marketing_start_date": "20231102", "listing_expiration_date": "20261231"}