Home NDC 71335-1594 Calcitriol
Product NDC 71335-1594
11-digit product format 713351594
Labeler code 71335
Product ID 71335-1594_2eef31a6-f775-43b5-bd03-f35ef5840821
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitriol
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA075765
Marketing category ANDA
Marketing start 2016-07-01
Substance CALCITRIOL
Active strength .5 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 A075765-001 CALCITRIOL CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 A075765-002 CALCITRIOL CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12
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 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075765-001 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2001-10-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075765-002 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2001-10-12 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 .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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 71335-1594-1 Calcitriol 30 in 1 BOTTLE CAPSULE, LIQUID FILLED 30 2 71335-1594-2 Calcitriol 8 in 1 BOTTLE CAPSULE, LIQUID FILLED 8 2 71335-1594-3 Calcitriol 28 in 1 BOTTLE CAPSULE, LIQUID FILLED 28 2 71335-1594-4 Calcitriol 90 in 1 BOTTLE CAPSULE, LIQUID FILLED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1594 CALCITRIOL CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK] 2 Current NDC, Legacy NDC, 4 package rows 20231118_7e0574e0-3a41-486a-be37-92ab56b7f81f.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 71335-1594-1 71335159401 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-1594-1) 2020-05-11 0000-00-00 No No Current 71335-1594-2 71335159402 8 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-1594-2) 2020-05-11 0000-00-00 No No Current 71335-1594-3 71335159403 28 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-1594-3) 2020-05-11 0000-00-00 No No Current 71335-1594-4 71335159404 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-1594-4) 2020-05-11 0000-00-00 No No Current