FDA.reportPublic FDA data

Calcium Acetate

Product NDC
29033-026
11-digit product format
290330026
Labeler code
29033
Product ID
29033-026_6ff0e3ce-3974-4fd7-b4cc-bbe90a86f45a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Nostrum Laboratories, Inc.
Application
ANDA203179
Marketing category
ANDA
Marketing start
2015-10-26
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
No
Listing certified through
2022-12-31
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
29033-026-022026-01-29C16284748780-149896155-ac4d-586f-e063-e6dba90add90These highlights do not include all the information needed to use CALCIUM ACETATE CAPSULES safely and effectively. See full prescribing information for CALCIUM ACETATE CAPSULES. CALCIUM ACETATE capsules, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29033-026-02Calcium Acetate200 in 1 BOTTLECAPSULE2005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM ACETATEACTIVE INGREDIENTY882YXF34XCALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29033-026CALCIUM ACETATE CAPSULE [NOSTRUM LABORATORIES, INC.]5Legacy NDC, 1 package rows20211103_f5fa3aa9-79d9-49de-a486-1af17d89786d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSNa8eee952-54b9-4680-bab6-f90f7e4efb6b6
359296calcium acetate 667 MG Oral CapsuleSCDa8eee952-54b9-4680-bab6-f90f7e4efb6b6
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSYa8eee952-54b9-4680-bab6-f90f7e4efb6b6
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSNf5fa3aa9-79d9-49de-a486-1af17d89786d5
359296calcium acetate 667 MG Oral CapsuleSCDf5fa3aa9-79d9-49de-a486-1af17d89786d5
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSYf5fa3aa9-79d9-49de-a486-1af17d89786d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29033-026-0229033002602200 CAPSULE in 1 BOTTLE (29033-026-02) 200 capsule2015-10-260000-00-00NoNoCurrent