Home NDC 68083-316 Calcitriol
Product NDC 68083-316
11-digit product format 680830316
Labeler code 68083
Product ID 68083-316_7e6d4205-3332-4f96-b258-8ffde9119ed4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitriol
Dosage form INJECTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA211030
Marketing category ANDA
Marketing start 2020-02-03
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 A211030-001 CALCITRIOL CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211030-001 AP
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.
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 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211030-001 CALCITRIOL 0.001MG/ML INJECTABLE / INJECTION AP 2020-02-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 308869 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 68083-316-10 Calcitriol 10 in 1 CARTON INJECTION 10 4 68083-316-10 Calcitriol 1 mL in 1 VIAL INJECTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-316 CALCITRIOL INJECTION [GLAND PHARMA LIMITED] 4 Current NDC, Legacy NDC, 2 package rows 20221011_d9ba544c-6ca8-410d-a306-51482a8c6848.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 · 2 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 68083-316-10 68083031610 10 VIAL in 1 CARTON (68083-316-10) / 1 mL in 1 VIAL 10 vial 2020-02-03 0000-00-00 No No Current