Home NDC 70954-831 Calcitriol
Product NDC 70954-831
11-digit product format 709540831
Labeler code 70954
Product ID 70954-831_bdb9c0d4-bdb3-4174-a4d9-55c423f38476
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitriol
Dosage form SOLUTION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA021068
Marketing category NDA
Marketing start 2026-05-13
Substance CALCITRIOL
Active strength 1 ug/mL
Pharmacologic classes Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 N021068-001 ROCALTROL CALCITRIOL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021068-001 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 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021068-001 ROCALTROL 1MCG/ML SOLUTION / ORAL AA RLD, RS 1998-11-20 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 2027-12-31 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 70954-831-10 Calcitriol 15 mL in 1 BOTTLE, GLASS SOLUTION 15 1 70954-831-10 Calcitriol 1 in 1 CARTON SOLUTION 1 1
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 Sample Exclude flag Status 70954-831-10 70954083110 1 BOTTLE, GLASS in 1 CARTON (70954-831-10) / 15 mL in 1 BOTTLE, GLASS 2026-05-13 No No Current