FDA.reportPublic FDA data

Calcium Gluconate

Product NDC
63323-360
11-digit product format
633230360
Labeler code
63323
Product ID
63323-360_3e4a7e0e-c7f4-4aa0-8c9c-0aa3fd7dc729
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Gluconate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA208418
Marketing category
NDA
Marketing start
2017-06-15
Substance
CALCIUM GLUCONATE MONOHYDRATE
Active strength
98 mg/mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calcium Gluconate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM GLUCONATE MONOHYDRATE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCZN0MI5R31
Rxcui197435, 1668248, 1668250

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-360-01Calcium Gluconate10 mL in 1 VIAL, PLASTICINJECTION, SOLUTION106
63323-360-03Calcium Gluconate50 mL in 1 VIAL, PLASTICINJECTION, SOLUTION506
63323-360-05Calcium Gluconate100 mL in 1 VIAL, PLASTICINJECTION, SOLUTION1006
63323-360-19Calcium Gluconate25 in 1 TRAYINJECTION, SOLUTION256
63323-360-59Calcium Gluconate25 in 1 TRAYINJECTION, SOLUTION256
63323-360-61Calcium Gluconate20 in 1 TRAYINJECTION, SOLUTION206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-360-01ML - Milliliter63323-3601d434d18-2915-46fe-a4fd-26c3adca017612017-10-13
63323-360-03ML - Milliliter63323-3605cc8d670-ba3a-4eec-b5dc-bec4a770a71c12017-10-13
63323-360-05ML - Milliliter63323-360353fb39c-9d1e-4a17-b179-6ab94782731912017-10-13
63323-360-19ML - Milliliter63323-360faa54ab9-88fe-45ad-998c-b85cd78b698612017-10-13
63323-360-59ML - Milliliter63323-360fa4b02da-a263-415b-aa3c-c0eb1618003d12017-10-13
63323-360-61ML - Milliliter63323-360322c87e1-c87a-4ced-b4cf-499d1c46841b12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-360CALCIUM GLUCONATE (CALCIUM GLUCONATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 6 package rows20230808_8b77c3d2-992d-4261-8421-9cfd07328fbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSN788ab6d7-d80c-0220-e053-2991aa0ae6e95
166825010 ML calcium gluconate 100 MG/ML InjectionSCD788ab6d7-d80c-0220-e053-2991aa0ae6e95
1668250calcium gluconate 10 % per 10 ML InjectionSY788ab6d7-d80c-0220-e053-2991aa0ae6e95
1668248calcium gluconate 5 GM in 50 ML (10 % ) InjectionPSN7d93251a-b555-0be0-e053-2991aa0ad7644
166824850 ML calcium gluconate 100 MG/ML InjectionSCD7d93251a-b555-0be0-e053-2991aa0ad7644
1668248calcium gluconate 10 % per 50 ML InjectionSY7d93251a-b555-0be0-e053-2991aa0ad7644
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSN4c635f60-7868-46d5-b932-d5cf8fc844323
166825010 ML calcium gluconate 100 MG/ML InjectionSCD4c635f60-7868-46d5-b932-d5cf8fc844323
1668250calcium gluconate 10 % per 10 ML InjectionSY4c635f60-7868-46d5-b932-d5cf8fc844323
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSN38413366-b558-7dd0-e063-6394a90acb7e2
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSNb6226367-b061-eec5-e053-2a95a90a617d2
166825010 ML calcium gluconate 100 MG/ML InjectionSCD38413366-b558-7dd0-e063-6394a90acb7e2
166825010 ML calcium gluconate 100 MG/ML InjectionSCDb6226367-b061-eec5-e053-2a95a90a617d2
1668250calcium gluconate 10 % per 10 ML InjectionSY38413366-b558-7dd0-e063-6394a90acb7e2
1668250calcium gluconate 10 % per 10 ML InjectionSYb6226367-b061-eec5-e053-2a95a90a617d2
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSNd98cdf54-0dce-459f-881f-3b6c6e6185fe1
166825010 ML calcium gluconate 100 MG/ML InjectionSCDd98cdf54-0dce-459f-881f-3b6c6e6185fe1
1668250calcium gluconate 10 % per 10 ML InjectionSYd98cdf54-0dce-459f-881f-3b6c6e6185fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-360-016332303600110 mL in 1 VIAL, PLASTIC10 mlHistorical
63323-360-036332303600350 mL in 1 VIAL, PLASTIC50 mlHistorical
63323-360-0563323036005100 mL in 1 VIAL, PLASTIC100 mlHistorical
63323-360-196332303601925 VIAL, PLASTIC in 1 TRAY (63323-360-19) / 10 mL in 1 VIAL, PLASTIC (63323-360-01) 2017-06-150000-00-00NoNoCurrent
63323-360-596332303605925 VIAL, PLASTIC in 1 TRAY (63323-360-59) / 50 mL in 1 VIAL, PLASTIC (63323-360-03) 2017-06-150000-00-00NoNoCurrent
63323-360-616332303606120 VIAL, PLASTIC in 1 TRAY (63323-360-61) / 100 mL in 1 VIAL, PLASTIC (63323-360-05) 2017-06-150000-00-00NoNoCurrent