FDA.reportPublic FDA data

Calcitriol

Product NDC
64380-723
Requested package NDC
64380-723-04
11-digit product format
643800723
Labeler code
64380
Product ID
64380-723_0c6ffbc5-f012-42c6-9847-c49e1708259b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol Capsules 0.25 mcg
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA091356
Marketing category
ANDA
Marketing start
2016-12-10
Substance
CALCITRIOL
Active strength
.25 ug/1
Pharmacologic classes
Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091356-001CALCITRIOLCALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12
A091356-002CALCITRIOLCALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091356-001AB
A091356-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12a50c72e98297…
2026-08-01 22:54:322026-06A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091356-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091356-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalcitriolCALCITRIOL CAPSULES 0.25 MCGStrides Pharma Science Limitedbebefb2a-7365-48e2-9681-83ed4b41e26e2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091356
application number: ANDA091356
ndc (package): 64380-723-04
ndc (product): 64380-723
ndc11 (package): 64380072304
CalcitriolCALCITRIOL CAPSULES 0.25 MCGCardinal Health 107, LLC32205cfc-7939-4105-a4b9-2ed327c5e0cc2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091356
application number: ANDA091356
CalcitriolCALCITRIOLChartwell RX, LLC36820cd0-7b30-4454-9005-09d71e1d57962025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091356
application number: ANDA091356
CalcitriolCALCITRIOL CAPSULES 0.25 MCGAmerican Health Packaging261398eb-80b8-4c3d-9d2b-3a8004347a752025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091356
application number: ANDA091356
CALCITRIOLCALCITRIOLHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2b48f57a-c023-485d-b846-cab3aaaad4862025-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091356
application number: ANDA091356
CalcitriolCALCITRIOL CAPSULES 0.25 MCGAphena Pharma Solutions - Tennessee, LLC29b8cc1f-0491-0a95-e063-6294a90a223d2024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091356
application number: ANDA091356
CALCITRIOLCALCITRIOLA-S Medication Solutions26ac6b4d-9576-4710-856b-aca114ea84cf2024-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091356
application number: ANDA091356
CalcitriolCALCITRIOL CAPSULES 0.25 MCGBryant Ranch Prepack3637da5e-55cf-40ed-9bea-18c27b5956272024-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091356
application number: ANDA091356

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCITRIOL.25 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FXC9231JVHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308867Internal RxNorm lookup
308868Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bebefb2a-7365-48e2-9681-83ed4b41e26eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
09b728d3-9521-67a6-95fe-30969d1d5187Product name520240828
5f07db61-095c-acca-e8e9-d0916b4c1947Product name220200616
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-723-04Calcitriol30 in 1 CONTAINERCAPSULE3011
64380-723-06Calcitriol100 in 1 CONTAINERCAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-723-04EA - Each64380-7238600d772-0fba-4fd6-bad8-40ad7d77745212015-02-02
64380-723-06EA - Each64380-723a656060a-49b7-46a9-9ff5-fb18bde0e27612015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UCALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3
SORBITOLINACTIVE INGREDIENT506T60A25RCALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES ARCOLAB LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-723CALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES PHARMA SCIENCE LIMITED]11Current NDC, Legacy NDC, 2 package rows20250311_bebefb2a-7365-48e2-9681-83ed4b41e26e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSNbebefb2a-7365-48e2-9681-83ed4b41e26e11
308868calcitriol 0.5 MCG Oral CapsulePSNbebefb2a-7365-48e2-9681-83ed4b41e26e11
308867calcitriol 0.00025 MG Oral CapsuleSCDbebefb2a-7365-48e2-9681-83ed4b41e26e11
308868calcitriol 0.0005 MG Oral CapsuleSCDbebefb2a-7365-48e2-9681-83ed4b41e26e11
308867calcitriol 0.25 MCG Oral CapsuleSYbebefb2a-7365-48e2-9681-83ed4b41e26e11
308868calcitriol 0.5 MCG Oral CapsuleSYbebefb2a-7365-48e2-9681-83ed4b41e26e11
308867calcitriol 0.25 MCG Oral CapsulePSN3637da5e-55cf-40ed-9bea-18c27b5956279
308868calcitriol 0.5 MCG Oral CapsulePSN3637da5e-55cf-40ed-9bea-18c27b5956279
308867calcitriol 0.00025 MG Oral CapsuleSCD3637da5e-55cf-40ed-9bea-18c27b5956279
308868calcitriol 0.0005 MG Oral CapsuleSCD3637da5e-55cf-40ed-9bea-18c27b5956279
308867calcitriol 0.25 MCG Oral CapsuleSY3637da5e-55cf-40ed-9bea-18c27b5956279
308868calcitriol 0.5 MCG Oral CapsuleSY3637da5e-55cf-40ed-9bea-18c27b5956279
308867calcitriol 0.25 MCG Oral CapsulePSN261398eb-80b8-4c3d-9d2b-3a8004347a755
308867calcitriol 0.00025 MG Oral CapsuleSCD261398eb-80b8-4c3d-9d2b-3a8004347a755
308867calcitriol 0.25 MCG Oral CapsuleSY261398eb-80b8-4c3d-9d2b-3a8004347a755
308867calcitriol 0.25 MCG Oral CapsulePSNc3d5546b-ccd4-4988-9d86-9f0b29e121282
308867calcitriol 0.00025 MG Oral CapsuleSCDc3d5546b-ccd4-4988-9d86-9f0b29e121282
308867calcitriol 0.25 MCG Oral CapsuleSYc3d5546b-ccd4-4988-9d86-9f0b29e121282
308867calcitriol 0.25 MCG Oral CapsulePSN29b8cc1f-0491-0a95-e063-6294a90a223d1
308867calcitriol 0.00025 MG Oral CapsuleSCD29b8cc1f-0491-0a95-e063-6294a90a223d1
308867calcitriol 0.25 MCG Oral CapsuleSY29b8cc1f-0491-0a95-e063-6294a90a223d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-723-046438007230430 CAPSULE in 1 CONTAINER (64380-723-04) 30 capsule2016-12-140000-00-00NoNoCurrent