FDA.reportPublic FDA data

calcium gluconate

Product NDC
0143-9184
11-digit product format
001439184
Labeler code
0143
Product ID
0143-9184_ce7becd8-cf59-4470-aac8-82761a24ebd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcium gluconate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA213071
Marketing category
ANDA
Marketing start
2023-11-24
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
Rxcui1668248

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
0143-9184-01calcium gluconate50 mL in 1 VIALINJECTION, SOLUTION501
0143-9184-25calcium gluconate25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9184-01ML - Milliliter0143-91848821c79b-385b-452c-b49b-4fcc4d2f590a12024-02-14
0143-9184-25ML - Milliliter0143-91844cbff8ae-4417-4294-b5e9-23dd6964de7912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9184CALCIUM GLUCONATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20231124_ce7becd8-cf59-4470-aac8-82761a24ebd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668248calcium gluconate 5 GM in 50 ML (10 % ) InjectionPSNce7becd8-cf59-4470-aac8-82761a24ebd71
166824850 ML calcium gluconate 100 MG/ML InjectionSCDce7becd8-cf59-4470-aac8-82761a24ebd71
1668248calcium gluconate 10 % per 50 ML InjectionSYce7becd8-cf59-4470-aac8-82761a24ebd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9184-010014391840150 mL in 1 VIAL50 mlHistorical
0143-9184-250014391842525 VIAL in 1 CARTON (0143-9184-25) / 50 mL in 1 VIAL (0143-9184-01) 25 vial2023-11-24NoNoHistorical