Home NDC 0054-0007 Calcitriol
Product NDC 0054-0007
11-digit product format 000540007
Labeler code 0054
Product ID 0054-0007_b5e53ff9-faab-4e0b-ae45-b3b2a4522557
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitriol
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA076917
Marketing category ANDA
Marketing start 2006-03-27
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0054-0007-13 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0054-0007-25 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0054-0007-13 bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0054-0007-25 bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076917-001 CALCITRIOL CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076917-001 AB
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 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Calcitriol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCITRIOL .25 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FXC9231JVH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308867 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-0007-13 Calcitriol 30 in 1 BOTTLE, PLASTIC CAPSULE 30 16 0054-0007-25 Calcitriol 100 in 1 BOTTLE, PLASTIC CAPSULE 100 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCITRIOL ACTIVE INGREDIENT FXC9231JVH CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 CALCITRIOL ACTIVE MOIETY FXC9231JVH CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CALCITRIOL CAPSULE [ROXANE LABORATORIES, INC.] 8 CALCITRIOL ACTIVE INGREDIENT FXC9231JVH CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CALCITRIOL ACTIVE MOIETY FXC9231JVH CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0007 CALCITRIOL CAPSULE [HIKMA PHARMACEUTICALS USA INC.] 15 Current NDC, Legacy NDC, 2 package rows 20240105_cdcaffc6-e14e-4607-b77b-fc78a8382f60.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0007-13 00054000713 30 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-13) 30 capsule 2006-03-27 0000-00-00 No No Current 0054-0007-25 00054000725 100 CAPSULE in 1 BOTTLE, PLASTIC (0054-0007-25) 100 capsule 2006-03-27 0000-00-00 No No Current