Calcium Acetate

Product NDC
75834-323
11-digit product format
758340323
Labeler code
75834
Product ID
75834-323_da6dc42d-1ae6-45ff-8a81-20a7135f8d17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcium Acetate
Dosage form
CAPSULE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA217205
Marketing category
ANDA
Marketing start
2023-12-07
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
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
75834-323-02Calcium Acetate200 in 1 BOTTLECAPSULE2001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-323-02EA - Each75834-3235418823d-6c78-46b3-917c-38477d2c4ee912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-323CALCIUM ACETATE CAPSULE [NIVAGEN PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20231207_da6dc42d-1ae6-45ff-8a81-20a7135f8d17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN925918d5-9f89-4f2f-9bb9-d9c53d90bb0a3
359296calcium acetate 667 MG Oral CapsuleSCD925918d5-9f89-4f2f-9bb9-d9c53d90bb0a3
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY925918d5-9f89-4f2f-9bb9-d9c53d90bb0a3
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSN7177829c-bd89-485c-b5e3-15e457e969c52
359296calcium acetate 667 MG Oral CapsuleSCD7177829c-bd89-485c-b5e3-15e457e969c52
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSY7177829c-bd89-485c-b5e3-15e457e969c52
359296calcium acetate 667 MG (Ca 169 MG) Oral CapsulePSNda6dc42d-1ae6-45ff-8a81-20a7135f8d171
359296calcium acetate 667 MG Oral CapsuleSCDda6dc42d-1ae6-45ff-8a81-20a7135f8d171
359296calcium acetate 667 MG (calcium 169 MG) Oral CapsuleSYda6dc42d-1ae6-45ff-8a81-20a7135f8d171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75834-323-0275834032302200 CAPSULE in 1 BOTTLE (75834-323-02) 200 capsule2023-12-07NoNoCurrent