FDA.reportPublic FDA data

CALCIUM ACETATE

Product NDC
68382-642
11-digit product format
683820642
Labeler code
68382
Product ID
68382-642_71154665-be56-47ef-8f1f-5997a6f86b2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CALCIUM ACETATE
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA202885
Marketing category
ANDA
Marketing start
2012-02-23
Marketing end
0000-00-00
Substance
CALCIUM ACETATE
Active strength
667 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68382-642-102020-01-31C16284748780-19d75b9d1-0999-f424-e053-dadaa90a57ceRx Only These highlights do not include all the information needed to use Calcium Acetate Tablets safely and effectively. See full prescribing information for Calcium Acetate Tablets. Calcium Acetate Tablets USP for ORAL use. Initial U.S. Approval: 1990
68382-642-662020-01-31C16284748780-19d75b9d1-0999-f424-e053-dadaa90a57ceRx Only These highlights do not include all the information needed to use Calcium Acetate Tablets safely and effectively. See full prescribing information for Calcium Acetate Tablets. Calcium Acetate Tablets USP for ORAL use. Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-642-10CALCIUM ACETATE1000 in 1 BOTTLETABLET10004
68382-642-66CALCIUM ACETATE200 in 1 BOTTLETABLET2004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE TABLET [ZYDUS PHARMACEUTICALS USA INC.]4
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ACETATE TABLET [ZYDUS PHARMACEUTICALS USA INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCALCIUM ACETATE TABLET [ZYDUS PHARMACEUTICALS USA INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ACETATE TABLET [ZYDUS PHARMACEUTICALS USA INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCALCIUM ACETATE TABLET [ZYDUS PHARMACEUTICALS USA INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-642CALCIUM ACETATE TABLET [ZYDUS PHARMACEUTICALS USA INC.]4Legacy NDC, 2 package rows20150204_f86caa76-047c-4be7-8c11-cba6c00a44ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197433calcium 169 MG Oral Tablet, as calcium acetatePSNf86caa76-047c-4be7-8c11-cba6c00a44ed4
197433calcium acetate 667 MG Oral TabletSCDf86caa76-047c-4be7-8c11-cba6c00a44ed4
197433calcium acetate 667 MG (calcium 169 MG) Oral TabletSYf86caa76-047c-4be7-8c11-cba6c00a44ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68382-642-10683820642101000 in 1 BOTTLEHistorical
68382-642-6668382064266200 in 1 BOTTLEHistorical