Doxercalciferol

Product NDC
0955-1722
11-digit product format
009551722
Labeler code
0955
Product ID
0955-1722_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
3 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0955-1722DDiscontinued by firm2026-10-15
excluded packagepackage0955-17220955-1722-50DDiscontinued by firm2026-10-15

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0955-1722-50DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0955-1722-50DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0955-1722-50DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0955-1722-50DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0955-1722-50DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0955-1722-50DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0955-1722-50DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0955-1722-50DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0955-1722-50DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0955-1722-50DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0955-1722-50DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0955-1722-50DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0955-1722-50IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020862-001HECTOROLDOXERCALCIFEROL2.5MCGCAPSULE / ORALRLD1999-06-09
N020862-002HECTOROLDOXERCALCIFEROL0.5MCGCAPSULE / ORALRLD2004-04-23
N020862-003HECTOROLDOXERCALCIFEROL1MCGCAPSULE / ORALRLD2009-07-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N020862-001M-142028-06-11
N020862-002M-142028-06-11
N020862-003M-142028-06-11

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020862-001HECTOROL2.5MCGCAPSULE / ORALRLD1999-06-09c2088c7a36db…
2026-10-15 13:18:302026-09N020862-002HECTOROL0.5MCGCAPSULE / ORALRLD2004-04-23c2088c7a36db…
2026-10-15 13:18:302026-09N020862-003HECTOROL1MCGCAPSULE / ORALRLD2009-07-13c2088c7a36db…
2026-09-14 22:38:342026-08N020862-001HECTOROL2.5MCGCAPSULE / ORALRLD1999-06-0984e616aacf4f…
2026-09-14 22:38:342026-08N020862-002HECTOROL0.5MCGCAPSULE / ORALRLD2004-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N020862-003HECTOROL1MCGCAPSULE / ORALRLD2009-07-1384e616aacf4f…
2026-08-18 06:07:402026-07N020862-001HECTOROL2.5MCGCAPSULE / ORALRLD1999-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07N020862-002HECTOROL0.5MCGCAPSULE / ORALRLD2004-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N020862-003HECTOROL1MCGCAPSULE / ORALRLD2009-07-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020862-001HECTOROL2.5MCGCAPSULE / ORALRLD1999-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020862-002HECTOROL0.5MCGCAPSULE / ORALRLD2004-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020862-003HECTOROL1MCGCAPSULE / ORALRLD2009-07-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020862-001HECTOROL2.5MCGCAPSULE / ORALRLD1999-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020862-002HECTOROL0.5MCGCAPSULE / ORALRLD2004-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020862-003HECTOROL1MCGCAPSULE / ORALRLD2009-07-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N020862-001HECTOROL2.5MCGCAPSULE / ORALABRLD, RS1999-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020862-002HECTOROL0.5MCGCAPSULE / ORALABRLD2004-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020862-003HECTOROL1MCGCAPSULE / ORALABRLD2009-07-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020862-001HECTOROL2.5MCGCAPSULE / ORALABRLD, RS1999-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020862-002HECTOROL0.5MCGCAPSULE / ORALABRLD2004-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020862-003HECTOROL1MCGCAPSULE / ORALABRLD2009-07-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020862-001HECTOROL2.5MCGCAPSULE / ORALABRLD, RS1999-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020862-002HECTOROL0.5MCGCAPSULE / ORALABRLD2004-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020862-003HECTOROL1MCGCAPSULE / ORALABRLD2009-07-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020862-001HECTOROL2.5MCGCAPSULE / ORALABRLD, RS1999-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020862-002HECTOROL0.5MCGCAPSULE / ORALABRLD2004-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020862-003HECTOROL1MCGCAPSULE / ORALABRLD2009-07-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020862-001HECTOROL2.5MCGCAPSULE / ORALABRLD, RS1999-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020862-002HECTOROL0.5MCGCAPSULE / ORALABRLD2004-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020862-003HECTOROL1MCGCAPSULE / ORALABRLD2009-07-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020862-001HECTOROL2.5MCGCAPSULE / ORALABRLD, RS1999-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020862-002HECTOROL0.5MCGCAPSULE / ORALABRLD2004-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020862-003HECTOROL1MCGCAPSULE / ORALABRLD2009-07-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020862-001HECTOROL2.5MCGCAPSULE / ORALABRLD, RS1999-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020862-002HECTOROL0.5MCGCAPSULE / ORALABRLD2004-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020862-003HECTOROL1MCGCAPSULE / ORALABRLD2009-07-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020862-001HECTOROL2.5MCGCAPSULE / ORALABRLD, RS1999-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N020862-002HECTOROL0.5MCGCAPSULE / ORALABRLD2004-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10N020862-003HECTOROL1MCGCAPSULE / ORALABRLD2009-07-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020862-001HECTOROL2.5MCGCAPSULE / ORALABRLD, RS1999-06-0979d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04N020862-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020862-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020862-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020862-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020862-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020862-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020862-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020862-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020862-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020862-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020862-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020862-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020862-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020862-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020862-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020862-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020862-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020862-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020862-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020862-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020862-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020862-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020862-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020862-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020862-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020862-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020862-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020862-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020862-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020862-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020862-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020862-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020862-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020862-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020862-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020862-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020862-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020862-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020862-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N020862-002AB11c564ffb4f44…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N020862-001M-142028-06-11c2088c7a36db…
2026-10-15 13:18:302026-09N020862-002M-142028-06-11c2088c7a36db…
2026-10-15 13:18:302026-09N020862-003M-142028-06-11c2088c7a36db…
2026-09-14 22:38:342026-08N020862-001M-142028-06-1184e616aacf4f…
2026-09-14 22:38:342026-08N020862-002M-142028-06-1184e616aacf4f…
2026-09-14 22:38:342026-08N020862-003M-142028-06-1184e616aacf4f…
2026-08-18 06:07:402026-07N020862-001M-142028-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N020862-002M-142028-06-11caaa826d4ba7…
2026-08-18 06:07:402026-07N020862-003M-142028-06-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020862-001M-142028-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020862-002M-142028-06-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020862-003M-142028-06-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020862-001M-142028-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020862-002M-142028-06-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020862-003M-142028-06-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020862-001M-142028-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020862-002M-142028-06-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020862-003M-142028-06-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020862-001M-142028-06-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020862-002M-142028-06-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020862-003M-142028-06-11a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1722-50EA - Each0955-172243db69f9-4f85-4f16-9f01-1cf78e8eb27712017-05-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0955-1722-50009551722501 BOTTLE in 1 CARTON (0955-1722-50) > 50 CAPSULE in 1 BOTTLE1 bottle2017-04-170000-00-00NoNoCurrent