Home NDC 0054-3120 Calcitriol
Product NDC 0054-3120
11-digit product format 000543120
Labeler code 0054
Product ID 0054-3120_2b8745f3-5289-474e-bd44-48b59a40dd78
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitriol
Dosage form SOLUTION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA076242
Marketing category ANDA
Marketing start 2003-07-18
Substance CALCITRIOL
Active strength 1 ug/mL
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 A076242-001 CALCITRIOL CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076242-001 AA
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 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076242-001 CALCITRIOL 1MCG/ML SOLUTION / ORAL AA 2003-07-18 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 1 ug/mL
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 313932 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 0054-3120-41 Calcitriol 15 mL in 1 BOTTLE, GLASS SOLUTION 15 15 0054-3120-41 Calcitriol 1 in 1 CARTON SOLUTION 1 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3120 CALCITRIOL SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 15 Current NDC, Legacy NDC, 2 package rows 20231107_3289b482-8733-484d-b1db-d7f4cdcd1ac2.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 Marketing start Marketing end Sample Exclude flag Status 0054-3120-41 00054312041 1 BOTTLE, GLASS in 1 CARTON (0054-3120-41) / 15 mL in 1 BOTTLE, GLASS 2003-07-18 0000-00-00 No No Current