Home NDC 0054-0339 Doxercalciferol
Product NDC 0054-0339
11-digit product format 000540339
Labeler code 0054
Product ID 0054-0339_3005b8c6-407e-4750-a100-3d47089bfaee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Doxercalciferol
Dosage form CAPSULE
Route ORAL
Labeler West-Ward Pharmaceuticals Corp.
Application ANDA091433
Marketing category ANDA
Marketing start 2014-02-18
Marketing end 0000-00-00
Substance DOXERCALCIFEROL
Active strength 3 ug/1
Pharmacologic classes Ergocalciferols [CS],Vitamin D2 Analog [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 36 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 0054-0339-19 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 0054-0339-19 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 0054-0339-19 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 0054-0339-19 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 0054-0339-19 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 0054-0339-19 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 0054-0339-19 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 0054-0339-19 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 0054-0339-19 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 0054-0339-19 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 0054-0339-19 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0054-0339-19 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0054-0339-19 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0054-0339-19 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0054-0339-19 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…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 0054-0339-19 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0054-0339-19 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0054-0339-19 I Inactivated by FDA bd6a592717d7…303034d00443…
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 A091433-001 DOXERCALCIFEROL DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 A091433-002 DOXERCALCIFEROL DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 A091433-003 DOXERCALCIFEROL DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14
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 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091433-002 DOXERCALCIFEROL 1MCG CAPSULE / ORAL 2014-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091433-003 DOXERCALCIFEROL 2.5MCG CAPSULE / ORAL 2014-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091433-001 DOXERCALCIFEROL 0.5MCG CAPSULE / ORAL 2011-09-23 8072bd15b7f6…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOXERCALCIFEROL ACTIVE INGREDIENT 3DIZ9LF5Y9 DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 DOXERCALCIFEROL ACTIVE MOIETY 3DIZ9LF5Y9 DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DOXERCALCIFEROL CAPSULE [ROXANE LABORATORIES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0339-19 00054033919 50 CAPSULE in 1 BOTTLE (0054-0339-19) 50 capsule 2014-02-18 0000-00-00 No No Current