Home NDC 43353-219 Ergocalciferol
Product NDC 43353-219
11-digit product format 433530219
Labeler code 43353
Product ID 43353-219_7d5d42ee-0533-4ade-9d04-8a58ec77b8f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ergocalciferol
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA040833
Marketing category ANDA
Marketing start 2011-11-15
Marketing end 0000-00-00
Substance ERGOCALCIFEROL
Active strength 1 mg/1
Pharmacologic classes Ergocalciferols [CS],Provitamin D2 Compound [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-219-03 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-219-08 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-219-04 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-219-03 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-219-08 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-219-04 f5e01cc5f278…a2eaf40c39c3…
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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-219 ERGOCALCIFEROL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC 20171012_4bedecb7-8c37-4a1c-81f6-0adfed636f37.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43353-219-03 43353021903 3 CAPSULE in 1 BOTTLE, PLASTIC (43353-219-03) 3 capsule 2017-05-26 0000-00-00 No No Current 43353-219-04 43353021904 4 CAPSULE in 1 BOTTLE, PLASTIC (43353-219-04) 4 capsule 2017-05-26 0000-00-00 No No Current 43353-219-08 43353021908 8 CAPSULE in 1 BOTTLE, PLASTIC (43353-219-08) 8 capsule 2017-08-25 0000-00-00 No No Current