Home NDC 30698-911 Rocaltrol
Product NDC 30698-911
11-digit product format 306980911
Labeler code 30698
Product ID 30698-911_73cbee56-369c-478d-84e8-df500e69dc82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcitriol
Dosage form SOLUTION
Route ORAL
Labeler Validus Pharmaceuticals LLC
Application NDA021068
Marketing category NDA
Marketing start 2009-07-23
Marketing end 0000-00-00
Substance CALCITRIOL
Active strength 1 ug/mL
Pharmacologic classes Cholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 30698-911-15 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 30698-911-15 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 30698-911-15 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 30698-911-15 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 30698-911-15 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 30698-911-15 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 30698-911-15 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 30698-911-15 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 30698-911-15 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 30698-911-15 Rocaltrol 15 mL in 1 BOTTLE SOLUTION 15 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCITRIOL ACTIVE INGREDIENT FXC9231JVH ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 CALCITRIOL ACTIVE MOIETY FXC9231JVH ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 PALM OIL INACTIVE INGREDIENT 5QUO05548Z ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30698-911 ROCALTROL (CALCITRIOL) CAPSULE, GELATIN COATED ROCALTROL (CALCITRIOL) SOLUTION [VALIDUS PHARMACEUTICALS LLC] 6 Legacy NDC, 1 package rows 20231215_d1013494-bf62-4e68-9f0c-e6571137f20f.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 30698-911-15 30698091115 15 mL in 1 BOTTLE (30698-911-15) 15 ml 2009-07-23 0000-00-00 No No Current