Home NDC 33261-730 Ergocalciferol
Product NDC 33261-730
11-digit product format 332610730
Labeler code 33261
Product ID 33261-730_42c39262-6a30-42e7-a2a8-5b1b98a0c851
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ergocalciferol
Dosage form CAPSULE
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA040833
Marketing category ANDA
Marketing start 2009-08-17
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 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040833-001 ERGOCALCIFEROL 50,000 IU CAPSULE / ORAL AA 2009-05-20 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 A040833-001 AA 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040833-001 AA 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A040833-001 AA 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 33261-730-08 VITAMIN D, ERGOCALCIFEROL Capsules, USP, 1.25 mg SOFTGEL CAPSULES (Soft Gelatin Capsules) (50,000 USP Units) 33261-730-12 VITAMIN D, ERGOCALCIFEROL Capsules, USP, 1.25 mg SOFTGEL CAPSULES (Soft Gelatin Capsules) (50,000 USP Units) 33261-730-13 VITAMIN D, ERGOCALCIFEROL Capsules, USP, 1.25 mg SOFTGEL CAPSULES (Soft Gelatin Capsules) (50,000 USP Units) 33261-730-30 VITAMIN D, ERGOCALCIFEROL Capsules, USP, 1.25 mg SOFTGEL CAPSULES (Soft Gelatin Capsules) (50,000 USP Units)
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33261-730-08 Ergocalciferol 8 in 1 BOTTLE, PLASTIC CAPSULE 8 1 33261-730-12 Ergocalciferol 12 in 1 BOTTLE, PLASTIC CAPSULE 12 1 33261-730-13 Ergocalciferol 4 in 1 BOTTLE, PLASTIC CAPSULE 4 1 33261-730-30 Ergocalciferol 30 in 1 BOTTLE, PLASTIC CAPSULE 30 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33261-730 ERGOCALCIFEROL CAPSULE [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 4 package rows 20140213_5ed8aad8-99ce-41e7-8c3d-26ecaf5599fd.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 Status 33261-730-08 33261073008 8 in 1 BOTTLE, PLASTIC Historical 33261-730-12 33261073012 12 in 1 BOTTLE, PLASTIC Historical 33261-730-13 33261073013 4 in 1 BOTTLE, PLASTIC Historical 33261-730-30 33261073030 30 in 1 BOTTLE, PLASTIC Historical