Home NDC 0054-0007-13 Calcitriol
Product NDC 0054-0007
Requested package NDC 0054-0007-13
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 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.
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 2026-08-01 22:54:32 2026-06 A076917-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2006-03-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A076917-001 AB 1 a50c72e98297…
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 · 3 matching rows.
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
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