Home NDC 72789-058 Calcitriol
Product NDC 72789-058
11-digit product format 727890058
Labeler code 72789
Product ID 72789-058_2c25214d-d149-70d8-e063-6394a90a7b08
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitriol
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, 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.
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 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 72789-058-01 Calcitriol 100 in 1 BOTTLE, PLASTIC CAPSULE 100 20 72789-058-30 Calcitriol 30 in 1 BOTTLE, PLASTIC CAPSULE 30 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-058 CALCITRIOL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 20 Current NDC, Legacy NDC, 2 package rows 20250121_e1fcb1c7-11a9-4a23-a64a-2c8ce9698321.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 72789-058-01 72789005801 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-01) 100 capsule 2020-02-26 0000-00-00 No No Current 72789-058-30 72789005830 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-058-30) 30 capsule 2023-07-14 No No Current