Home NDC 0955-1721 Doxercalciferol
Product NDC 0955-1721
11-digit product format 009551721
Labeler code 0955
Product ID 0955-1721_af718b86-0241-4e8b-9a93-c1933a11636e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxercalciferol
Dosage form CAPSULE
Route ORAL
Labeler Winthrop U.S, a business of sanofi-aventis U.S. LLC
Application NDA020862
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2017-04-17
Marketing end 0000-00-00
Substance DOXERCALCIFEROL
Active strength 1 ug/1
Pharmacologic classes Ergocalciferols [CS], Vitamin D2 Analog [EPC]
NDC exclude flag No
Listing certified through 2024-12-31
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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0955-1721-50 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0955-1721-50 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0955-1721-50 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0955-1721-50 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0955-1721-50 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0955-1721-50 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0955-1721-50 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0955-1721-50 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0955-1721-50 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0955-1721-50 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0955-1721-50 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0955-1721-50 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0955-1721-50 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020862-001 HECTOROL DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL RLD 1999-06-09 N020862-002 HECTOROL DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL RLD 2004-04-23 N020862-003 HECTOROL DOXERCALCIFEROL 1MCG CAPSULE / ORAL RLD 2009-07-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N020862-001 M-14 2028-06-11 N020862-002 M-14 2028-06-11 N020862-003 M-14 2028-06-11
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 4 · 123 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 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL RLD 1999-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL RLD 2004-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020862-003 HECTOROL 1MCG CAPSULE / ORAL RLD 2009-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL RLD 1999-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL RLD 2004-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020862-003 HECTOROL 1MCG CAPSULE / ORAL RLD 2009-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020862-002 HECTOROL 0.5MCG CAPSULE / ORAL AB RLD 2004-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020862-003 HECTOROL 1MCG CAPSULE / ORAL AB RLD 2009-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020862-001 HECTOROL 2.5MCG CAPSULE / ORAL AB RLD, RS 1999-06-09 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Observed Orange Book exclusivity history# FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0955-1721-50 00955172150 1 BOTTLE in 1 CARTON (0955-1721-50) > 50 CAPSULE in 1 BOTTLE 1 bottle 2017-04-17 0000-00-00 No No Current