NDC 68830-319 - Calcitriol

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: 68830-319
Package NDCs from labels: 68830-319-80
Manufacturer: NEPHRX, LLC
Effective date: 2009-01-27
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Calcitriol - NEPHRX, LLC	NEPHRX, LLC	2009-01-27	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68830-319-80	Calcitriol	1 mL in 1 AMPULE	SOLUTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68830-319	CALCITRIOL SOLUTION [NEPHRX, LLC]	1	1 package rows	20090210_045f46c7-c637-443b-8427-c461b3d7ca55.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Calcitriol	ACTIVE INGREDIENT	FXC9231JVH	CALCITRIOL SOLUTION [NEPHRX, LLC]	1
Calcitriol	ACTIVE MOIETY	FXC9231JVH	CALCITRIOL SOLUTION [NEPHRX, LLC]	1
dibasic sodium phosphate, anhydrous	INACTIVE INGREDIENT		CALCITRIOL SOLUTION [NEPHRX, LLC]	1
edetate disodium, dihydrate	INACTIVE INGREDIENT		CALCITRIOL SOLUTION [NEPHRX, LLC]	1
monobasic sodium phosphate, dihydrate	INACTIVE INGREDIENT		CALCITRIOL SOLUTION [NEPHRX, LLC]	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	CALCITRIOL SOLUTION [NEPHRX, LLC]	1
sodium ascorbate	INACTIVE INGREDIENT	S033EH8359	CALCITRIOL SOLUTION [NEPHRX, LLC]	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	CALCITRIOL SOLUTION [NEPHRX, LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CALCITRIOL SOLUTION [NEPHRX, LLC]	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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	FOSUN PHARMA USA INC	fe7ea4da-bda0-bb00-e053-6394a90a94e7	2024-05-02	Warnings, Adverse reactions	Exact identifier rxcui: 308869
Calcitriol	CALCITRIOL	Gland Pharma Limited	d9ba544c-6ca8-410d-a306-51482a8c6848	2022-10-10	Warnings, Adverse reactions	Exact identifier rxcui: 308869
42815939-F0D4-2B3E-BF53-F37CEAD9CF10			045f46c7-c637-443b-8427-c461b3d7ca55	2009-01-27	Warnings, Adverse reactions	Exact identifier spl id: 42815939-F0D4-2B3E-BF53-F37CEAD9CF10 spl set id: 045f46c7-c637-443b-8427-c461b3d7ca55

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.