Home NDC 84540-522 R Cos
Product NDC 84540-522
11-digit product format 845400522
Labeler code 84540
Product ID 84540-522_3d539cd6-a948-369c-e063-6294a90add5f
Type HUMAN OTC DRUG
Nonproprietary name Calcium Carbonate
Dosage form TABLET
Route ORAL
Labeler NPG Bio Pharmaceuticals Co.,Ltd.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-11
Substance CALCIUM CARBONATE
Active strength 90 mg/500mg
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base R Cos
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 90 mg/500mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H0G9379FGK Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84540-522-01 R Cos 500 mg in 1 BLISTER PACK TABLET 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84540-522 R COS (CALCIUM CARBONATE) TABLET [NPG BIO PHARMACEUTICALS CO.,LTD.] 3 Current NDC, 1 package rows 20241223_21fa767a-1344-5ed9-e063-6394a90a5fe6.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 14 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84540-522-01 84540052201 500 mg in 1 BLISTER PACK (84540-522-01) 500 mg 2024-09-11 No No Current