FDA.reportPublic FDA data

Calcium Gluconate in Sodium Chloride

Product NDC
44567-621
11-digit product format
445670621
Labeler code
44567
Product ID
44567-621_323609e8-1364-4118-a016-89ba36e5ce2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Gluconate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
NDA210906
Marketing category
NDA
Marketing start
2018-10-26
Substance
CALCIUM GLUCONATE MONOHYDRATE
Active strength
20 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 in Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM GLUCONATE MONOHYDRATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCZN0MI5R31
Rxcui2117608, 2117610

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-621-01Calcium Gluconate in Sodium Chloride100 mL in 1 BAGINJECTION, SOLUTION10015
44567-621-01Calcium Gluconate in Sodium Chloride1 in 1 POUCHINJECTION, SOLUTION115
44567-621-24Calcium Gluconate in Sodium Chloride24 in 1 CARTONINJECTION, SOLUTION2415
44567-621-02Calcium Gluconate in Sodium Chloride1 in 1 POUCHINJECTION, SOLUTION13
44567-621-02Calcium Gluconate in Sodium Chloride100 mL in 1 BAGINJECTION, SOLUTION1003
44567-621-84Calcium Gluconate in Sodium Chloride24 in 1 CARTONINJECTION, SOLUTION243

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-621-01ML - Milliliter44567-62197d71e93-794d-4a64-b942-046e5868b0fa12019-08-06
44567-621-02ML - Milliliter44567-62191f63e83-0713-4d92-9c22-b8204d3bc44512025-05-14
44567-621-24ML - Milliliter44567-621aa74588d-eb0f-4160-a394-07f3927e72c312019-08-06
44567-621-84ML - Milliliter44567-621f509424d-14f9-4835-ba7d-51baf10081db12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-621CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE) INJECTION, SOLUTION [WG CRITICAL CARE, LLC]12Current NDC, Legacy NDC, 3 package rows20230926_e6d531ec-fcdc-49f6-b0c4-878d3952827f.zip
44567-621CALCIUM GLUCONATE IN SODIUM CHLORIDE (CALCIUM GLUCONATE) INJECTION, SOLUTION [WG CRITICAL CARE, LLC]1Current NDC, Legacy NDC, 3 package rows20240214_0deed071-d89d-420e-b4b4-797dce0ad8f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2562542calcium gluconate 1000 MG in 100 ML InjectionPSNe6d531ec-fcdc-49f6-b0c4-878d3952827f15
2117610calcium gluconate 1000 MG in 50 mL InjectionPSNe6d531ec-fcdc-49f6-b0c4-878d3952827f15
2117608calcium gluconate 2000 MG in 100 ML InjectionPSNe6d531ec-fcdc-49f6-b0c4-878d3952827f15
2562542100 ML calcium gluconate 10 MG/ML InjectionSCDe6d531ec-fcdc-49f6-b0c4-878d3952827f15
2117608100 ML calcium gluconate 20 MG/ML InjectionSCDe6d531ec-fcdc-49f6-b0c4-878d3952827f15
211761050 ML calcium gluconate 20 MG/ML InjectionSCDe6d531ec-fcdc-49f6-b0c4-878d3952827f15
2562542calcium gluconate 1000 MG per 100 ML InjectionSYe6d531ec-fcdc-49f6-b0c4-878d3952827f15
2117610calcium gluconate 1000 MG per 50 ML InjectionSYe6d531ec-fcdc-49f6-b0c4-878d3952827f15
2117608calcium gluconate 2000 MG per 100 ML InjectionSYe6d531ec-fcdc-49f6-b0c4-878d3952827f15
2117610calcium gluconate 1000 MG in 50 mL InjectionPSN0deed071-d89d-420e-b4b4-797dce0ad8f03
2117608calcium gluconate 2000 MG in 100 ML InjectionPSN0deed071-d89d-420e-b4b4-797dce0ad8f03
2117608100 ML calcium gluconate 20 MG/ML InjectionSCD0deed071-d89d-420e-b4b4-797dce0ad8f03
211761050 ML calcium gluconate 20 MG/ML InjectionSCD0deed071-d89d-420e-b4b4-797dce0ad8f03
2117610calcium gluconate 1000 MG per 50 ML InjectionSY0deed071-d89d-420e-b4b4-797dce0ad8f03
2117608calcium gluconate 2000 MG per 100 ML InjectionSY0deed071-d89d-420e-b4b4-797dce0ad8f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-621-0144567062101100 mL in 1 BAG100 mlHistorical
44567-621-02445670621021 in 1 POUCHHistorical
44567-621-244456706212424 POUCH in 1 CARTON (44567-621-24) / 1 BAG in 1 POUCH (44567-621-01) / 100 mL in 1 BAG24 pouch2018-10-260000-00-00NoNoCurrent
44567-621-844456706218424 POUCH in 1 CARTON (44567-621-84) / 1 BAG in 1 POUCH (44567-621-02) / 100 mL in 1 BAG24 pouch2024-02-12NoNoHistorical