CALCITRIOL

Product NDC
63304-239
11-digit product format
633040239
Labeler code
63304
Product ID
63304-239_ccc0e02b-bd1e-45f2-9256-6933ac193518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CALCITRIOL
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA018044
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-08-26
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63304-239IInactivated by FDA2026-08-10
excluded packagepackage63304-23963304-239-01IInactivated by FDA2026-08-10
excluded packagepackage63304-23963304-239-30IInactivated by FDA2026-08-10

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
N018044-001ROCALTROLCALCITRIOL0.25MCGCAPSULE / ORALABRLD, Approved before 1982
N018044-002ROCALTROLCALCITRIOL0.5MCGCAPSULE / ORALABRLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018044-001AB
N018044-002AB

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 UTC2026-02N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018044-001ROCALTROL0.25MCGCAPSULE / ORALABRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N018044-002ROCALTROL0.5MCGCAPSULE / ORALABRLD, RS, Approved before 1982782e0a99824c…

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 UTC2026-02N018044-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018044-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018044-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018044-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018044-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018044-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018044-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018044-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018044-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018044-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018044-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018044-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018044-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018044-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018044-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018044-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018044-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018044-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018044-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018044-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018044-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018044-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018044-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018044-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018044-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018044-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018044-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018044-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018044-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018044-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018044-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018044-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018044-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018044-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018044-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018044-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018044-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018044-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018044-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N018044-002AB1782e0a99824c…

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
63304-239-01CALCITRIOL100 in 1 BOTTLECAPSULE1004
63304-239-30CALCITRIOL30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-239-01EA - Each63304-239e7c394b1-e51a-42b4-a9f1-f8a324c81c1312012-07-24
63304-239-30EA - Each63304-239433d5c69-7d9a-4d35-8dea-6df0279a53d612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
PALM OILINACTIVE INGREDIENT5QUO05548ZCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
SORBITOLINACTIVE INGREDIENT506T60A25RCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL CAPSULE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-239CALCITRIOL CAPSULE CALCITRIOL SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Current NDC, Legacy NDC, 2 package rows20180823_66a69351-5b09-4368-a9fa-acf81b5ad882.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSN66a69351-5b09-4368-a9fa-acf81b5ad8824
308868calcitriol 0.5 MCG Oral CapsulePSN66a69351-5b09-4368-a9fa-acf81b5ad8824
313932calcitriol 1 MCG in 1 mL Oral SolutionPSN66a69351-5b09-4368-a9fa-acf81b5ad8824
308867calcitriol 0.00025 MG Oral CapsuleSCD66a69351-5b09-4368-a9fa-acf81b5ad8824
308868calcitriol 0.0005 MG Oral CapsuleSCD66a69351-5b09-4368-a9fa-acf81b5ad8824
313932calcitriol 0.001 MG/ML Oral SolutionSCD66a69351-5b09-4368-a9fa-acf81b5ad8824
308867calcitriol 0.25 MCG Oral CapsuleSY66a69351-5b09-4368-a9fa-acf81b5ad8824
308868calcitriol 0.5 MCG Oral CapsuleSY66a69351-5b09-4368-a9fa-acf81b5ad8824
313932calcitriol 1 MCG per 1 ML Oral SolutionSY66a69351-5b09-4368-a9fa-acf81b5ad8824
308867calcitriol 0.25 MCG Oral CapsulePSN2d755a21-9f42-4d36-aaec-962495ab2f2b2
308867calcitriol 0.00025 MG Oral CapsuleSCD2d755a21-9f42-4d36-aaec-962495ab2f2b2
308867calcitriol 0.25 MCG Oral CapsuleSY2d755a21-9f42-4d36-aaec-962495ab2f2b2
308867calcitriol 0.25 MCG Oral CapsulePSNc64778c6-3be6-44f5-8387-ebcd82e3eae51
308867calcitriol 0.00025 MG Oral CapsuleSCDc64778c6-3be6-44f5-8387-ebcd82e3eae51
308867calcitriol 0.25 MCG Oral CapsuleSYc64778c6-3be6-44f5-8387-ebcd82e3eae51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63304-239-0163304023901100 CAPSULE in 1 BOTTLE (63304-239-01) 100 capsule2009-08-260000-00-00NoNoCurrent
63304-239-306330402393030 CAPSULE in 1 BOTTLE (63304-239-30) 30 capsule2009-08-260000-00-00NoNoCurrent