FDA.reportPublic FDA data

Calcium Chloride

Product NDC
76329-3304
11-digit product format
763293304
Labeler code
76329
Product ID
76329-3304_fe9c2714-4299-4327-96cd-cf3ab03efcde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS; INTRAVENTRICULAR
Labeler
International Medication Systems, Limited
Application
ANDA203477
Marketing category
ANDA
Marketing start
2018-07-08
Substance
CALCIUM CHLORIDE
Active strength
100 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 Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM CHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM4I0D6VV5M
Rxcui828527

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
76329-3304-1Calcium Chloride10 in 1 PACKAGEINJECTION109
76329-3304-1Calcium Chloride10 mL in 1 SYRINGEINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-3304-1ML - Milliliter76329-330465d97f45-431e-4b7a-98cc-29afd8b898c212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Calcium ChlorideACTIVE INGREDIENTM4I0D6VV5MCALCIUM CHLORIDE (CALCIUM CHLORIDE ) INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]3
Calcium CationACTIVE MOIETY2M83C4R6ZBCALCIUM CHLORIDE (CALCIUM CHLORIDE ) INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]3
Calcium HydroxideINACTIVE INGREDIENTPF5DZW74VNCALCIUM CHLORIDE (CALCIUM CHLORIDE ) INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]3
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBCALCIUM CHLORIDE (CALCIUM CHLORIDE ) INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-3304CALCIUM CHLORIDE (CALCIUM CHLORIDE ) INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ]8Current NDC, Legacy NDC, 2 package rows20230708_8295039b-2559-4626-90c8-6ac7e896e41a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN8295039b-2559-4626-90c8-6ac7e896e41a9
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD8295039b-2559-4626-90c8-6ac7e896e41a9
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY8295039b-2559-4626-90c8-6ac7e896e41a9
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN994a17da-4430-9489-e053-2a95a90acb7c5
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD994a17da-4430-9489-e053-2a95a90acb7c5
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY994a17da-4430-9489-e053-2a95a90acb7c5
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN6b15706b-199c-beba-e053-2991aa0a17343
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN801f110c-7800-4689-a37a-f31d99c0f9303
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD6b15706b-199c-beba-e053-2991aa0a17343
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD801f110c-7800-4689-a37a-f31d99c0f9303
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY6b15706b-199c-beba-e053-2991aa0a17343
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY801f110c-7800-4689-a37a-f31d99c0f9303
828527calcium chloride 10 % in 10 ML Prefilled SyringePSN3eef0115-26f6-2abe-e063-6294a90aa2891
82852710 ML calcium chloride 100 MG/ML Prefilled SyringeSCD3eef0115-26f6-2abe-e063-6294a90aa2891
828527calcium chloride 10 % in 10 ML Prefilled SyringeSY3eef0115-26f6-2abe-e063-6294a90aa2891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76329-3304-17632933040110 SYRINGE in 1 PACKAGE (76329-3304-1) / 10 mL in 1 SYRINGE10 syringe2018-07-080000-00-00NoNoCurrent