FDA.reportPublic FDA data

Calcium Gluconate

Product NDC
65219-164
11-digit product format
652190164
Labeler code
65219
Product ID
65219-164_3351b72a-aa15-419f-a58c-4df90573d9f9
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
2021-06-17
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
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
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
65219-164-01Calcium Gluconate100 mL in 1 BAGINJECTION, SOLUTION1004
65219-164-50Calcium Gluconate24 in 1 CASEINJECTION, SOLUTION244

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-164-01ML - Milliliter65219-1642c4b4dc5-f54b-478e-a284-b46fd0103e7b12022-05-04
65219-164-50ML - Milliliter65219-164c49d39a9-7b1b-4c65-af81-e1f12b25875a12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-164CALCIUM GLUCONATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20240509_7f5101e0-abf9-4fcf-8986-c799e3333434.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2117610calcium gluconate 1000 MG in 50 mL InjectionPSN7f5101e0-abf9-4fcf-8986-c799e33334344
2117608calcium gluconate 2000 MG in 100 ML InjectionPSN7f5101e0-abf9-4fcf-8986-c799e33334344
2117608100 ML calcium gluconate 20 MG/ML InjectionSCD7f5101e0-abf9-4fcf-8986-c799e33334344
211761050 ML calcium gluconate 20 MG/ML InjectionSCD7f5101e0-abf9-4fcf-8986-c799e33334344
2117610calcium gluconate 1000 MG per 50 ML InjectionSY7f5101e0-abf9-4fcf-8986-c799e33334344
2117608calcium gluconate 2000 MG per 100 ML InjectionSY7f5101e0-abf9-4fcf-8986-c799e33334344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-164-0165219016401100 mL in 1 BAG100 mlHistorical
65219-164-506521901645024 BAG in 1 CASE (65219-164-50) / 100 mL in 1 BAG (65219-164-01) 24 bag2021-06-170000-00-00NoNoCurrent