FDA.reportPublic FDA data

Calcium Acetate

Product NDC
62135-191
11-digit product format
621350191
Labeler code
62135
Product ID
62135-191_06d3e4e6-38bb-e690-e063-6294a90af4d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA091312
Marketing category
ANDA
Marketing start
2018-06-29
Substance
CALCIUM ACETATE
Active strength
667 mg/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
62135-191-22Calcium Acetate200 in 1 BOTTLECAPSULE2005
62135-191-30Calcium Acetate30 in 1 BOTTLECAPSULE305
62135-191-73Calcium Acetate750 in 1 BOTTLECAPSULE7505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-191-22EA - Each62135-1912dbaafd9-281a-4b4e-b7af-40a0cc49ac8b12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-191CALCIUM ACETATE CAPSULE [CHARTWELL RX, LLC.]5Current NDC, Legacy NDC, 3 package rows20231004_781c3f1f-b622-418b-8c0e-3407e9b90656.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN781c3f1f-b622-418b-8c0e-3407e9b906565
359296calcium acetate 667 MG Oral CapsuleSCD781c3f1f-b622-418b-8c0e-3407e9b906565
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY781c3f1f-b622-418b-8c0e-3407e9b906565
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN489f35f6-28a4-47dc-8abf-6ce403afa9cc1
359296calcium acetate 667 MG Oral CapsuleSCD489f35f6-28a4-47dc-8abf-6ce403afa9cc1
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY489f35f6-28a4-47dc-8abf-6ce403afa9cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-191-2262135019122200 CAPSULE in 1 BOTTLE (62135-191-22) 200 capsule2018-06-290000-00-00NoNoCurrent
62135-191-306213501913030 CAPSULE in 1 BOTTLE (62135-191-30) 30 capsule2018-06-290000-00-00NoNoCurrent
62135-191-7362135019173750 CAPSULE in 1 BOTTLE (62135-191-73) 750 capsule2018-06-290000-00-00NoNoCurrent