Home NDC 42806-733 CALCITRIOL
Product NDC 42806-733
11-digit product format 428060733
Labeler code 42806
Product ID 42806-733_51ae0d1a-48cf-091b-e063-6394a90aff4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CALCITRIOL
Dosage form CAPSULE
Route ORAL
Labeler EPIC PHARMA LLC
Application ANDA219796
Marketing category ANDA
Marketing start 2026-02-27
Substance CALCITRIOL
Active strength .5 ug/1
Pharmacologic classes Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219796-001 CALCITRIOL CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2026-02-27 A219796-002 CALCITRIOL CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2026-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219796-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2026-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219796-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2026-02-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219796-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219796-002 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base CALCITRIOL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCITRIOL .5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308867 Internal RxNorm lookup 308868 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42806-733-01 CALCITRIOL 100 in 1 BOTTLE CAPSULE 100 3
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42806-733-01 42806073301 100 CAPSULE in 1 BOTTLE (42806-733-01) 100 capsule 2026-02-27 No No Current