FDA.reportPublic FDA data

Calcium Acetate

Product NDC
69097-862
11-digit product format
690970862
Labeler code
69097
Product ID
69097-862_7749772b-1a26-4b2e-b97d-3ee29611d035
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.,
Application
ANDA203135
Marketing category
ANDA
Marketing start
2016-07-26
Substance
CALCIUM ACETATE
Active strength
667 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calcium Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM ACETATE667 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY882YXF34X
Rxcui359296

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
69097-862-03Calcium Acetate60 in 1 BOTTLECAPSULE606
69097-862-83Calcium Acetate200 in 1 BOTTLECAPSULE2006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-862-83EA - Each69097-8621d651387-77da-4b71-a4d2-dce96bf5860712016-08-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-862CALCIUM ACETATE CAPSULE [CIPLA USA INC.,]6Current NDC, Legacy NDC, 2 package rows20230316_000c044a-12ef-4484-942e-99552b777d58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN000c044a-12ef-4484-942e-99552b777d586
359296calcium acetate 667 MG Oral CapsuleSCD000c044a-12ef-4484-942e-99552b777d586
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY000c044a-12ef-4484-942e-99552b777d586
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN9ad4e86c-5f52-4d53-b294-8233f2cd9f581
359296calcium acetate 667 MG Oral CapsuleSCD9ad4e86c-5f52-4d53-b294-8233f2cd9f581
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY9ad4e86c-5f52-4d53-b294-8233f2cd9f581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-862-036909708620360 CAPSULE in 1 BOTTLE (69097-862-03) 60 capsule2016-07-260000-00-00NoNoCurrent
69097-862-8369097086283200 CAPSULE in 1 BOTTLE (69097-862-83) 200 capsule2016-07-260000-00-00NoNoCurrent