calcium gluconate

Product NDC
75834-171
11-digit product format
758340171
Labeler code
75834
Product ID
75834-171_b99af4e6-74c3-4a4f-85f2-6dcc0a759449
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcium gluconate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA213071
Marketing category
ANDA
Marketing start
2022-10-24
Marketing end
0000-00-00
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]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
75834-171-01calcium gluconate10 mL in 1 VIALINJECTION, SOLUTION103
75834-171-19calcium gluconate25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-171-01ML - Milliliter75834-171cb06d12e-798d-4c8c-baee-af6f763e3b3912022-12-07
75834-171-19ML - Milliliter75834-171599e8018-0a9e-42c3-a445-1843728a44ca12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-171CALCIUM GLUCONATE INJECTION, SOLUTION [NIVAGEN PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20221024_0522051a-d044-4cee-acbc-378a607b4855.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1668250calcium gluconate 1 GM in 10 ML (10 % ) InjectionPSN0522051a-d044-4cee-acbc-378a607b48553
166825010 ML calcium gluconate 100 MG/ML InjectionSCD0522051a-d044-4cee-acbc-378a607b48553
1668250calcium gluconate 10 % per 10 ML InjectionSY0522051a-d044-4cee-acbc-378a607b48553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-171-017583401710110 mL in 1 VIAL10 mlHistorical
75834-171-197583401711925 VIAL in 1 CARTON (75834-171-19) > 10 mL in 1 VIAL (75834-171-01) 25 vial2022-10-240000-00-00NoNoCurrent