Rocaltrol

Product NDC
30698-144
11-digit product format
306980144
Labeler code
30698
Product ID
30698-144_73cbee56-369c-478d-84e8-df500e69dc82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcitriol
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Validus Pharmaceuticals LLC
Application
NDA018044
Marketing category
NDA
Marketing start
2009-08-20
Marketing end
0000-00-00
Substance
CALCITRIOL
Active strength
1 ug/1
Pharmacologic classes
Cholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct30698-144IInactivated by FDA2026-08-10
excluded packagepackage30698-14430698-144-01IInactivated 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
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30698-144-012025-01-31C16284748780-1f386c64a-273c-0266-e053-dadaa90a7c1aROCALTROL
30698-144-012023-12-14C16284748780-1f386c64a-273c-0266-e053-dadaa90a7c1aROCALTROL
30698-144-012023-01-30C16284748780-1f386c64a-273c-0266-e053-dadaa90a7c1aROCALTROL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30698-144-01Rocaltrol100 in 1 BOTTLECAPSULE, GELATIN COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-144-01EA - Each30698-144968f39c4-e0ba-47ab-b0be-7e71be4ea0c012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITRIOLACTIVE INGREDIENTFXC9231JVHROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
CALCITRIOLACTIVE MOIETYFXC9231JVHROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
PALM OILINACTIVE INGREDIENT5QUO05548ZROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-144ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC]6Legacy NDC, 1 package rows20231215_d1013494-bf62-4e68-9f0c-e6571137f20f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308867calcitriol 0.25 MCG Oral CapsulePSNd1013494-bf62-4e68-9f0c-e6571137f20f6
308868calcitriol 0.5 MCG Oral CapsulePSNd1013494-bf62-4e68-9f0c-e6571137f20f6
313932calcitriol 1 MCG in 1 mL Oral SolutionPSNd1013494-bf62-4e68-9f0c-e6571137f20f6
209006Rocaltrol 0.25 MCG Oral CapsulePSNd1013494-bf62-4e68-9f0c-e6571137f20f6
209007Rocaltrol 0.5 MCG Oral CapsulePSNd1013494-bf62-4e68-9f0c-e6571137f20f6
261283Rocaltrol 1 MCG in 1 mL Oral SolutionPSNd1013494-bf62-4e68-9f0c-e6571137f20f6
209006calcitriol 0.00025 MG Oral Capsule [Rocaltrol]SBDd1013494-bf62-4e68-9f0c-e6571137f20f6
209007calcitriol 0.0005 MG Oral Capsule [Rocaltrol]SBDd1013494-bf62-4e68-9f0c-e6571137f20f6
261283calcitriol 0.001 MG/ML Oral Solution [Rocaltrol]SBDd1013494-bf62-4e68-9f0c-e6571137f20f6
308867calcitriol 0.00025 MG Oral CapsuleSCDd1013494-bf62-4e68-9f0c-e6571137f20f6
308868calcitriol 0.0005 MG Oral CapsuleSCDd1013494-bf62-4e68-9f0c-e6571137f20f6
313932calcitriol 0.001 MG/ML Oral SolutionSCDd1013494-bf62-4e68-9f0c-e6571137f20f6
308867calcitriol 0.25 MCG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
308868calcitriol 0.5 MCG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
313932calcitriol 1 MCG per 1 ML Oral SolutionSYd1013494-bf62-4e68-9f0c-e6571137f20f6
209006Rocaltrol 0.00025 MG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
209007Rocaltrol 0.0005 MG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
261283Rocaltrol 0.001 MG/ML Oral SolutionSYd1013494-bf62-4e68-9f0c-e6571137f20f6
209006Rocaltrol 0.25 MCG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
209007Rocaltrol 0.5 MCG Oral CapsuleSYd1013494-bf62-4e68-9f0c-e6571137f20f6
261283Rocaltrol 1 MCG per 1 ML Oral SolutionSYd1013494-bf62-4e68-9f0c-e6571137f20f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
30698-144-0130698014401100 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-144-01) 2009-08-200000-00-00NoNoCurrent