FDA.reportPublic FDA data

CALCIUM GLUCONATE

Product NDC
80830-2363
11-digit product format
808302363
Labeler code
80830
Product ID
80830-2363_2bd614b6-02ce-49e3-86e2-dfaec7a13e04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcium gluconate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals Private Limited
Application
ANDA217174
Marketing category
ANDA
Marketing start
2023-09-08
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
80830-2363-2CALCIUM GLUCONATE1 in 1 POUCHINJECTION, SOLUTION116
80830-2363-2CALCIUM GLUCONATE12 in 1 CARTONINJECTION, SOLUTION1216
80830-2363-9CALCIUM GLUCONATE24 in 1 CARTONINJECTION, SOLUTION2416
80830-2363-9CALCIUM GLUCONATE1 in 1 POUCHINJECTION, SOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80830-2363-1ML - Milliliter80830-2363c280cfda-f4cd-49e5-aa82-370851426c8e12023-10-16
80830-2363-2ML - Milliliter80830-2363f282305d-852a-44ed-953e-ae8bf25051cb12024-02-14
80830-2363-9ML - Milliliter80830-2363e615c832-cfac-41c6-896f-7114bba7504e12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80830-2363CALCIUM GLUCONATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED]16Current NDC, 4 package rows20250522_8ee79b4c-21d3-4742-ae37-e2f562917706.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2117610calcium gluconate 1000 MG in 50 mL InjectionPSN8ee79b4c-21d3-4742-ae37-e2f56291770616
2117608calcium gluconate 2000 MG in 100 ML InjectionPSN8ee79b4c-21d3-4742-ae37-e2f56291770616
2117608100 ML calcium gluconate 20 MG/ML InjectionSCD8ee79b4c-21d3-4742-ae37-e2f56291770616
211761050 ML calcium gluconate 20 MG/ML InjectionSCD8ee79b4c-21d3-4742-ae37-e2f56291770616
2117610calcium gluconate 1000 MG per 50 ML InjectionSY8ee79b4c-21d3-4742-ae37-e2f56291770616
2117608calcium gluconate 2000 MG per 100 ML InjectionSY8ee79b4c-21d3-4742-ae37-e2f56291770616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80830-2363-28083023630212 POUCH in 1 CARTON (80830-2363-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG12 pouch2023-11-08NoNoCurrent
80830-2363-98083023630924 POUCH in 1 CARTON (80830-2363-9) / 1 BAG in 1 POUCH / 100 mL in 1 BAG24 pouch2023-09-08NoNoCurrent