Home Applications 040833 Application 040833
Type ANDA
Sponsor ORIT LABS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ERGOCALCIFEROL ERGOCALCIFEROL CAPSULE;ORAL 50,000 IU No No
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 A040833-001 ERGOCALCIFEROL ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040833-001 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 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0179-0204 Ergocalciferol Ergocalciferol KAISER FOUNDATION HOSPITALS ANDA Current 10544-527 Ergocalciferol Ergocalciferol Blenheim Pharmacal, Inc. ANDA Current 33261-730 Ergocalciferol Ergocalciferol Aidarex Pharmaceuticals LLC ANDA Current 43353-219 Ergocalciferol Ergocalciferol Aphena Pharma Solutions - Tennessee, LLC ANDA Current 50090-2083 Ergocalciferol Ergocalciferol A-S Medication Solutions ANDA Current 51407-143 ERGOCALCIFEROL ERGOCALCIFEROL Golden State Medical Supply Inc ANDA Current 51407-143 ERGOCALCIFEROL ERGOCALCIFEROL Golden State Medical Supply, Inc. ANDA Current 51407-143 ERGOCALCIFEROL ERGOCALCIFEROL Golden State Medical Supply, Inc. ANDA Current 51407-143 ERGOCALCIFEROL ERGOCALCIFEROL Golden State Medical Supply, Inc. ANDA Current 51407-143 ERGOCALCIFEROL ERGOCALCIFEROL Golden State Medical Supply, Inc. ANDA Current 51991-604 Ergocalciferol Ergocalciferol Breckenridge Pharmaceutical, Inc. ANDA Current 60429-245 Ergocalciferol Ergocalciferol Golden State Medical Supply, Inc. ANDA Current 60429-245 Ergocalciferol Ergocalciferol Golden State Medical Supply, Inc. ANDA Current 60687-500 Ergocalciferol Ergocalciferol American Health Packaging ANDA Current 60687-500 Ergocalciferol Ergocalciferol American Health Packaging ANDA Current 60687-500 Ergocalciferol Ergocalciferol American Health Packaging ANDA Current 60760-749 Ergocalciferol Ergocalciferol St Marys Medical Park Pharmacy ANDA Current 62135-439 Ergocalciferol Ergocalciferol Chartwell RX, LLC ANDA Current 62332-464 ERGOCALCIFEROL ERGOCALCIFEROL Alembic Pharmaceuticals Inc. ANDA Current 62332-464 ERGOCALCIFEROL ERGOCALCIFEROL Alembic Pharmaceuticals Inc. ANDA Current 62332-464 ERGOCALCIFEROL ERGOCALCIFEROL Alembic Pharmaceuticals Inc. ANDA Current 63629-3748 Ergocalciferol Ergocalciferol Bryant Ranch Prepack ANDA Current 63629-3748 Ergocalciferol Ergocalciferol Bryant Ranch Prepack ANDA Current 66336-907 Ergocalciferol Ergocalciferol Dispensing Solutions, Inc. ANDA Current 68084-463 Ergocalciferol Ergocalciferol American Health Packaging ANDA Current 71610-240 ERGOCALCIFEROL ERGOCALCIFEROL Aphena Pharma Solutions - Tennessee, LLC ANDA Current 71610-240 ERGOCALCIFEROL ERGOCALCIFEROL Aphena Pharma Solutions - Tennessee, LLC ANDA Current