FDA.reportPublic FDA data

CALCIUM GLUCONATE

Product NDC
70069-728
11-digit product format
700690728
Labeler code
70069
Product ID
70069-728_42dd49af-172b-4202-ab5c-442fa942a491
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CALCIUM GLUCONATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA217689
Marketing category
ANDA
Marketing start
2023-10-20
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
Rxcui197435, 1668248

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
70069-728-01CALCIUM GLUCONATE100 mL in 1 VIAL, PLASTICINJECTION, SOLUTION1006
70069-728-10CALCIUM GLUCONATE10 in 1 CARTONINJECTION, SOLUTION106
70069-728-10CALCIUM GLUCONATE100 mL in 1 VIAL, PLASTICINJECTION, SOLUTION1006
70069-728-20CALCIUM GLUCONATE20 in 1 CARTONINJECTION, SOLUTION206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-728-01ML - Milliliter70069-7280c44d908-7be4-455b-a6d4-940a5fd3910312025-02-10
70069-728-10ML - Milliliter70069-728ffae91c4-ea66-4eed-82f5-a75d0c99126412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-728CALCIUM GLUCONATE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]6Current NDC, 4 package rows20250209_fb40eba7-04e5-40dc-8a95-5f45e7bd70bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197435calcium gluconate 100 MG/ML (10 % ) Injectable SolutionPSNfb40eba7-04e5-40dc-8a95-5f45e7bd70bc6
1668248calcium gluconate 5 GM in 50 ML (10 % ) InjectionPSNfb40eba7-04e5-40dc-8a95-5f45e7bd70bc6
166824850 ML calcium gluconate 100 MG/ML InjectionSCDfb40eba7-04e5-40dc-8a95-5f45e7bd70bc6
197435calcium gluconate 100 MG/ML Injectable SolutionSCDfb40eba7-04e5-40dc-8a95-5f45e7bd70bc6
197435calcium gluconate 10 % Injectable SolutionSYfb40eba7-04e5-40dc-8a95-5f45e7bd70bc6
1668248calcium gluconate 10 % per 50 ML InjectionSYfb40eba7-04e5-40dc-8a95-5f45e7bd70bc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-728-0170069072801100 mL in 1 VIAL, PLASTIC100 mlHistorical
70069-728-107006907281010 VIAL, PLASTIC in 1 CARTON (70069-728-10) / 100 mL in 1 VIAL, PLASTIC2024-03-27NoNoHistorical
70069-728-207006907282020 VIAL, PLASTIC in 1 CARTON (70069-728-20) / 100 mL in 1 VIAL, PLASTIC (70069-728-01) 2023-10-20NoNoHistorical