Home NDC 71610-468 Calcitriol
Product NDC 71610-468
11-digit product format 716100468
Labeler code 71610
Product ID 71610-468_e4a50edb-a1aa-436f-9379-63010ae70dae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitriol
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA091174
Marketing category ANDA
Marketing start 2013-05-24
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091174-001 CALCITRIOL CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 A091174-002 CALCITRIOL CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24
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.
Product history page 1 of 3 · 82 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 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091174-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2013-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091174-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2013-05-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Calcitriol
Listing expiration 2026-12-31 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-468-09 Calcitriol 9000 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 9000 2 71610-468-30 Calcitriol 30 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-468 CALCITRIOL CAPSULE, LIQUID FILLED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20230615_3c40c40c-1627-4bcd-ba35-bee9b952d985.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71610-468-09 71610046809 9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-09) 2020-09-21 0000-00-00 No No Current 71610-468-30 71610046830 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-30) 2023-06-12 No No Current