Calcitriol

Product NDC
64380-724
Requested package NDC
64380-724-06
11-digit product format
643800724
Labeler code
64380
Product ID
64380-724_0c6ffbc5-f012-42c6-9847-c49e1708259b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol Capsules 0.5 mcg
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA091356
Marketing category
ANDA
Marketing start
2016-12-27
Substance
CALCITRIOL
Active strength
.5 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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091356-002CALCITRIOL0.5MCGCAPSULE / ORALABRS2014-12-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091356-002CALCITRIOL0.5MCGCAPSULE / ORALAB2014-12-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091356-002CALCITRIOL0.5MCGCAPSULE / ORALAB2014-12-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091356-002CALCITRIOL0.5MCGCAPSULE / ORALAB2014-12-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091356-002CALCITRIOL0.5MCGCAPSULE / ORALAB2014-12-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091356-002CALCITRIOL0.5MCGCAPSULE / ORALAB2014-12-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091356-001CALCITRIOL0.25MCGCAPSULE / ORALAB2014-12-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A091356-002CALCITRIOL0.5MCGCAPSULE / ORALAB2014-12-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091356-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091356-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091356-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091356-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091356-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091356-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091356-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091356-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091356-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091356-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091356-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091356-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091356-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091356-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091356-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091356-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091356-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091356-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091356-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091356-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091356-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091356-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091356-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091356-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091356-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091356-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091356-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091356-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091356-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091356-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091356-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091356-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091356-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091356-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091356-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091356-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091356-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091356-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091356-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091356-002AB1782e0a99824c…

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 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
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-724-06Calcitriol100 in 1 CONTAINERCAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-724-06EA - Each64380-7248ca954e8-6989-4776-b80c-6cc6bb78f77c12015-02-02

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
64380-724CALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE [STRIDES PHARMA SCIENCE LIMITED]11Current NDC, Legacy NDC, 1 package rows20250311_bebefb2a-7365-48e2-9681-83ed4b41e26e.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 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): 64380-724-06
ndc (product): 64380-724
ndc11 (package): 64380072406
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-724-0664380072406100 CAPSULE in 1 CONTAINER (64380-724-06) 100 capsule2016-12-270000-00-00NoNoCurrent