Home NDC 65162-576 Calcitriol
Product NDC 65162-576
11-digit product format 651620576
Labeler code 65162
Product ID 65162-576_ef9469b2-7a07-48f6-b7be-8a8ae57f08e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitriol
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA203289
Marketing category ANDA
Marketing start 2017-06-18
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 A203289-001 CALCITRIOL CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 A203289-002 CALCITRIOL CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14
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 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203289-001 CALCITRIOL 0.5MCG CAPSULE / ORAL AB 2017-06-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203289-002 CALCITRIOL 0.25MCG CAPSULE / ORAL AB 2017-06-14 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 · 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 65162-576-03 Calcitriol 30 in 1 BOTTLE CAPSULE 30 10 65162-576-10 Calcitriol 100 in 1 BOTTLE CAPSULE 100 10 65162-576-25 Calcitriol 250 in 1 BOTTLE CAPSULE 250 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-576 CALCITRIOL CAPSULE [AMNEAL PHARMACEUTICALS LLC] 10 Current NDC, Legacy NDC, 3 package rows 20241025_b1fef137-63c5-4662-8cd9-b9e8b12bacb6.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 · 1 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 65162-576-03 65162057603 30 CAPSULE in 1 BOTTLE (65162-576-03) 30 capsule 2017-06-18 0000-00-00 No No Current 65162-576-10 65162057610 100 CAPSULE in 1 BOTTLE (65162-576-10) 100 capsule 2017-06-18 0000-00-00 No No Current 65162-576-25 65162057625 250 CAPSULE in 1 BOTTLE (65162-576-25) 250 capsule 2017-06-18 0000-00-00 No No Current