FDA.reportPublic FDA data

calcium gluconate

Product NDC
0143-9180
11-digit product format
001439180
Labeler code
0143
Product ID
0143-9180_313a4ea9-178b-495e-9bc7-af1860fa6501
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
2023-10-16
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
Rxcui1668250

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
0143-9180-01calcium gluconate10 mL in 1 VIALINJECTION, SOLUTION101
0143-9180-25calcium gluconate25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9180CALCIUM GLUCONATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20231016_313a4ea9-178b-495e-9bc7-af1860fa6501.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSNd6db3a1c-ed02-48fc-9134-ea1d58acf42e2
166825010 ML calcium gluconate 100 MG/ML InjectionSCDd6db3a1c-ed02-48fc-9134-ea1d58acf42e2
1668250calcium gluconate 10 % per 10 ML InjectionSYd6db3a1c-ed02-48fc-9134-ea1d58acf42e2
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSN313a4ea9-178b-495e-9bc7-af1860fa65011
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSN3cbf6bf7-2415-4435-b3df-41855514a05d1
166825010 ML calcium gluconate 100 MG/ML InjectionSCD313a4ea9-178b-495e-9bc7-af1860fa65011
166825010 ML calcium gluconate 100 MG/ML InjectionSCD3cbf6bf7-2415-4435-b3df-41855514a05d1
1668250calcium gluconate 10 % per 10 ML InjectionSY313a4ea9-178b-495e-9bc7-af1860fa65011
1668250calcium gluconate 10 % per 10 ML InjectionSY3cbf6bf7-2415-4435-b3df-41855514a05d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9180-010014391800110 mL in 1 VIAL10 mlHistorical
0143-9180-250014391802525 VIAL in 1 CARTON (0143-9180-25) / 10 mL in 1 VIAL (0143-9180-01) 25 vial2023-10-16NoNoHistorical