FDA.reportPublic FDA data

Calcium Acetate

Product NDC
10135-629
11-digit product format
101350629
Labeler code
10135
Product ID
10135-629_be68d77b-9f64-4603-b529-3a15835438ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA203298
Marketing category
ANDA
Marketing start
2017-05-01
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
2020-12-31
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
10135-629-022021-01-29C16284748780-1ba0f9c33-2a55-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CALCIUM ACETATE safely and effectively. See full prescribing information for CALCIUM ACETATE. CALCIUM ACETATE capsules: 667 mg, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-629-02Calcium Acetate200 in 1 BOTTLECAPSULE2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-629-02EA - Each10135-629e0b925e8-fa7f-458f-a2c2-e7e378b0c1fd12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-629CALCIUM ACETATE CAPSULE [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 1 package rows20191112_eeb5471b-b6c9-46f5-89ca-5fe3b4ebf93d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSNeeb5471b-b6c9-46f5-89ca-5fe3b4ebf93d3
359296calcium acetate 667 MG Oral CapsuleSCDeeb5471b-b6c9-46f5-89ca-5fe3b4ebf93d3
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSYeeb5471b-b6c9-46f5-89ca-5fe3b4ebf93d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-629-0210135062902200 in 1 BOTTLEHistorical