FDA.reportPublic FDA data

Calcitriol

Product NDC
69452-208
11-digit product format
694520208
Labeler code
69452
Product ID
69452-208_4cc5e1b9-405a-106b-e063-6394a90af342
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
BIONPHARMA INC.
Application
ANDA091174
Marketing category
ANDA
Marketing start
2018-06-12
Substance
CALCITRIOL
Active strength
.5 ug/1
Pharmacologic classes
Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calcitriol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCITRIOL.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFXC9231JVH
Rxcui308867, 308868

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
09b728d3-9521-67a6-95fe-30969d1d5187Product name520240828
5f07db61-095c-acca-e8e9-d0916b4c1947Product name220200616
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-208-13Calcitriol30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED304
69452-208-20Calcitriol100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-208-20EA - Each69452-20860fb7586-9904-40e7-a4fd-06c6705e62bc12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-208CALCITRIOL CAPSULE, LIQUID FILLED [BIONPHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20250212_626f23d5-31e6-41ca-a696-191a4f2bc7ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308868calcitriol 0.5 MCG Oral CapsulePSNbf621b22-b783-416f-aee3-e0dbfdb782ca103
308868calcitriol 0.0005 MG Oral CapsuleSCDbf621b22-b783-416f-aee3-e0dbfdb782ca103
308868calcitriol 0.5 MCG Oral CapsuleSYbf621b22-b783-416f-aee3-e0dbfdb782ca103
308867calcitriol 0.25 MCG Oral CapsulePSN8465337c-86ca-ea9d-e053-2991aa0ab1677
308868calcitriol 0.5 MCG Oral CapsulePSN8465337c-86ca-ea9d-e053-2991aa0ab1677
308867calcitriol 0.00025 MG Oral CapsuleSCD8465337c-86ca-ea9d-e053-2991aa0ab1677
308868calcitriol 0.0005 MG Oral CapsuleSCD8465337c-86ca-ea9d-e053-2991aa0ab1677
308867calcitriol 0.25 MCG Oral CapsuleSY8465337c-86ca-ea9d-e053-2991aa0ab1677
308868calcitriol 0.5 MCG Oral CapsuleSY8465337c-86ca-ea9d-e053-2991aa0ab1677
308867calcitriol 0.25 MCG Oral CapsulePSN626f23d5-31e6-41ca-a696-191a4f2bc7ef4
308868calcitriol 0.5 MCG Oral CapsulePSN626f23d5-31e6-41ca-a696-191a4f2bc7ef4
308867calcitriol 0.00025 MG Oral CapsuleSCD626f23d5-31e6-41ca-a696-191a4f2bc7ef4
308868calcitriol 0.0005 MG Oral CapsuleSCD626f23d5-31e6-41ca-a696-191a4f2bc7ef4
308867calcitriol 0.25 MCG Oral CapsuleSY626f23d5-31e6-41ca-a696-191a4f2bc7ef4
308868calcitriol 0.5 MCG Oral CapsuleSY626f23d5-31e6-41ca-a696-191a4f2bc7ef4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-208-136945202081330 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-208-13) 2018-06-120000-00-00NoNoCurrent
69452-208-2069452020820100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (69452-208-20) 2018-06-120000-00-00NoNoCurrent