Home NDC 43353-828 VITAMIN D
Product NDC 43353-828
11-digit product format 433530828
Labeler code 43353
Product ID 43353-828_9e948241-a8c1-46e2-98c8-9c10893556b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ergocalciferol
Dosage form CAPSULE
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA040865
Marketing category ANDA
Marketing start 2010-03-15
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 2019-12-31
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 2 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A040865-001 ERGOCALCIFEROL ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29
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 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL 2009-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040865-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-12-29 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 43353-828-03 VITAMIN D 3 in 1 BOTTLE, PLASTIC CAPSULE 3 1 43353-828-04 VITAMIN D 4 in 1 BOTTLE, PLASTIC CAPSULE 4 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ERGOCALCIFEROL ACTIVE INGREDIENT VS041H42XC VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ERGOCALCIFEROL ACTIVE MOIETY VS041H42XC VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-828 VITAMIN D (ERGOCALCIFEROL) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 2 package rows 20130731_15f453ac-84b6-455e-9926-f51b8b9ac0dd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-828-03 43353082803 3 in 1 BOTTLE, PLASTIC Historical 43353-828-04 43353082804 4 in 1 BOTTLE, PLASTIC Historical