Application 018044
- Type
- NDA
- Sponsor
- VALIDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROCALTROL | CALCITRIOL | CAPSULE;ORAL | 0.25MCG | Yes | No |
| 002 | ROCALTROL | CALCITRIOL | CAPSULE;ORAL | 0.5MCG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018044-001 | ROCALTROL | CALCITRIOL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | |
| N018044-002 | ROCALTROL | CALCITRIOL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018044-001 | AB |
| N018044-002 | AB |
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 | 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 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018044-001 | ROCALTROL | 0.25MCG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018044-002 | ROCALTROL | 0.5MCG | CAPSULE / ORAL | AB | RLD, RS, Approved before 1982 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N018044-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018044-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018044-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018044-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018044-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018044-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018044-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018044-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018044-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018044-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018044-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018044-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018044-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018044-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018044-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018044-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018044-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018044-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018044-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018044-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018044-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018044-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018044-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018044-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018044-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018044-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018044-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N018044-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018044-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018044-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018044-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N018044-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018044-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N018044-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018044-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N018044-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018044-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N018044-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N018044-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N018044-002 | AB | 1 | 782e0a99824c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Calcitriol | CALCITRIOL | Bryant Ranch Prepack | bf621b22-b783-416f-aee3-e0dbfdb782ca | 2026-07-15 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | ANI Pharmaceuticals, Inc. | bdb9c0d4-bdb3-4174-a4d9-55c423f38476 | 2026-07-10 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Hikma Pharmaceuticals USA Inc. | cdcaffc6-e14e-4607-b77b-fc78a8382f60 | 2026-07-10 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Golden State Medical Supply, Inc. | 8465337c-86ca-ea9d-e053-2991aa0ab167 | 2026-07-06 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | BIONPHARMA INC. | 626f23d5-31e6-41ca-a696-191a4f2bc7ef | 2026-06-22 | Warnings, Adverse reactions | CALCITRIOL |
| CALCITRIOL | CALCITRIOL | EPIC PHARMA LLC | 554a54a0-3e46-4a9d-8e54-3d853302dbbb | 2026-05-13 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Chartwell RX, LLC | 36820cd0-7b30-4454-9005-09d71e1d5796 | 2025-12-09 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Bryant Ranch Prepack | 34f53d71-78b0-5237-e063-6294a90a2bbd | 2025-05-12 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Rising Pharma Holdings, Inc. | 1bd717a4-5fdf-4697-a6b2-9df55c6517bb | 2025-04-18 | Warnings, Adverse reactions | CALCITRIOL |
| CALCITRIOL | CALCITRIOL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 2b48f57a-c023-485d-b846-cab3aaaad486 | 2025-03-10 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | PD-Rx Pharmaceuticals, Inc. | e1fcb1c7-11a9-4a23-a64a-2c8ce9698321 | 2025-01-20 | Warnings, Adverse reactions | CALCITRIOL |
| CALCITRIOL | CALCITRIOL | A-S Medication Solutions | 26ac6b4d-9576-4710-856b-aca114ea84cf | 2024-12-12 | Warnings, Adverse reactions | CALCITRIOL |
| Vectical | CALCITRIOL | Galderma Laboratories, L.P. | a1567da9-af74-4afd-9ac5-8b53ec5d7cbf | 2024-10-24 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Amneal Pharmaceuticals LLC | b1fef137-63c5-4662-8cd9-b9e8b12bacb6 | 2024-10-23 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Bryant Ranch Prepack | 38a676c3-c6c6-4008-87df-f32e1cbaba9b | 2024-08-20 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Bryant Ranch Prepack | 6c68beb7-1fed-4652-b4e1-672fde0b621d | 2024-08-14 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | FOSUN PHARMA USA INC | fe7ea4da-bda0-bb00-e053-6394a90a94e7 | 2024-05-02 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Bryant Ranch Prepack | 7e0574e0-3a41-486a-be37-92ab56b7f81f | 2023-11-17 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | Patrin Pharma, Inc | c5c37779-0c26-438f-b1ca-61cf9915d233 | 2023-10-02 | Warnings, Adverse reactions | CALCITRIOL |
| Calcitriol | CALCITRIOL | A-S Medication Solutions | b57feb9f-2c5c-4d1c-9330-09c6e9fed95c | 2023-10-02 | Warnings, Adverse reactions | CALCITRIOL |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 30698-143 | Rocaltrol | calcitriol | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-143 | Rocaltrol | calcitriol | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-144 | Rocaltrol | calcitriol | Validus Pharmaceuticals LLC | NDA | Current |
| 30698-144 | Rocaltrol | calcitriol | Validus Pharmaceuticals LLC | NDA | Current |
| 43353-138 | CALCITRIOL | CALCITRIOL | Aphena Pharma Solutions - Tennessee, LLC | NDA AUTHORIZED GENERIC | Current |
| 43353-633 | Rocaltrol | calcitriol | Aphena Pharma Solutions - Tennessee, Inc. | NDA | Current |
| 63304-239 | CALCITRIOL | CALCITRIOL | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 63304-240 | CALCITRIOL | CALCITRIOL | Sun Pharmaceutical Industries, Inc. | NDA AUTHORIZED GENERIC | Current |
| 66336-851 | CALCITRIOL | CALCITRIOL | Dispensing Solutions, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68151-0088 | CALCITRIOL | CALCITRIOL | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |