Home NDC 0004-0143 NDC 0004-0143 - Rocaltrol This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 0004-0143
Package NDCs from labels 0004-0143-23, 0004-0143-01
Manufacturer Roche Pharmaceuticals
Effective date 2006-10-23
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Labels# Label, Manufacturer, Effective date table Label Manufacturer Effective date Type Rocaltrol - Roche Pharmaceuticals Roche Pharmaceuticals 2006-10-23 HUMAN PRESCRIPTION DRUG LABELING
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0004-0143-01 Rocaltrol 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 1 0004-0143-23 Rocaltrol 30 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0004-0143 ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 2 package rows 20061122_DC293A1C-995D-40FA-AC99-68DF12EB6D9E.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded calcitriol ACTIVE INGREDIENT FXC9231JVH ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 calcitriol ACTIVE MOIETY FXC9231JVH ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 butylated hydroxyanisole INACTIVE INGREDIENT ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 butylated hydroxytoluene INACTIVE INGREDIENT ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 FD&C Red No. 3 INACTIVE INGREDIENT ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 FD&C Yellow No. 6 INACTIVE INGREDIENT ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 fractionated triglyceride of coconut oil INACTIVE INGREDIENT ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 fractionated triglyceride of palm seed oil INACTIVE INGREDIENT ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 gelatin INACTIVE INGREDIENT 2G86QN327L ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 methylparaben INACTIVE INGREDIENT ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 sorbitol INACTIVE INGREDIENT 506T60A25R ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ROCALTROL (CALCITRIOL) CAPSULE, LIQUID FILLED ROCALTROL (CALCITRIOL) SOLUTION [ROCHE PHARMACEUTICALS] 1
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 2 of 2 · 28 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calcitriol CALCITRIOL Patrin Pharma, Inc c5c37779-0c26-438f-b1ca-61cf9915d233 2023-10-02 Warnings, Adverse reactions Exact identifier rxcui: 313932 Calcitriol CALCITRIOL A-S Medication Solutions b57feb9f-2c5c-4d1c-9330-09c6e9fed95c 2023-10-02 Warnings, Adverse reactions Exact identifier rxcui: 308867 Calcitriol CALCITRIOL Hikma Pharmaceuticals USA Inc. 3289b482-8733-484d-b1db-d7f4cdcd1ac2 2023-07-31 Warnings, Adverse reactions Exact identifier rxcui: 313932 Calcitriol CALCITRIOL Aphena Pharma Solutions - Tennessee, LLC 3c40c40c-1627-4bcd-ba35-bee9b952d985 2023-06-13 Warnings, Adverse reactions Exact identifier rxcui: 308867 Calcitriol CALCITRIOL Sun Pharmaceutical Industries, Inc. 97cf7807-3b48-403b-bae2-2fe585946e0c 2022-01-17 Warnings, Adverse reactions Exact identifier rxcui: 308868 rxcui: 308867 Calcitriol CALCITRIOL Aphena Pharma Solutions - Tennessee, LLC adb1b2d5-33a7-4442-9074-cc1a89966528 2021-03-14 Warnings, Adverse reactions Exact identifier rxcui: 308867 Calcitriol CALCITRIOL Teva Pharmaceuticals USA, Inc. ec93b667-aad2-4e3a-adc6-952f070a0c0a 2019-08-01 Warnings, Adverse reactions Exact identifier rxcui: 308868 rxcui: 308867 DC293A1C-995D-40FA-AC99-68DF12EB6D9E DC293A1C-995D-40FA-AC99-68DF12EB6D9E 2006-10-23 Warnings, Adverse reactions Exact identifier spl id: DC293A1C-995D-40FA-AC99-68DF12EB6D9E spl set id: DC293A1C-995D-40FA-AC99-68DF12EB6D9E
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.