Calcium Gluconate

Product NDC
70518-4178
11-digit product format
705184178
Labeler code
70518
Product ID
70518-4178_3ff0b519-50f1-93a8-e063-6294a90a9994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Gluconate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
NDA208418
Marketing category
NDA
Marketing start
2024-09-20
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM GLUCONATE MONOHYDRATE98 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCZN0MI5R31
Rxcui1668250

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
70518-4178-0Calcium Gluconate25 in 1 TRAYINJECTION, SOLUTION253
70518-4178-1Calcium Gluconate10 mL in 1 VIAL, PLASTICINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4178CALCIUM GLUCONATE INJECTION, SOLUTION [REMEDYREPACK INC.]2Current NDC, 2 package rows20250122_4c635f60-7868-46d5-b932-d5cf8fc84432.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4178-07051841780025 VIAL, PLASTIC in 1 TRAY (70518-4178-0) / 10 mL in 1 VIAL, PLASTIC (70518-4178-1) 2024-09-20NoNoHistorical
70518-4178-17051841780110 mL in 1 VIAL, PLASTIC10 mlHistorical