Calcitriol

Product NDC
23155-118
11-digit product format
231550118
Labeler code
23155
Product ID
23155-118_b39c295e-6187-46d1-9790-bccc300ea8a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcitriol
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc
Application
ANDA091174
Marketing category
ANDA
Marketing start
2013-05-29
Marketing end
0000-00-00
Substance
CALCITRIOL
Active strength
0 ug/1
Pharmacologic classes
Cholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct23155-118DDiscontinued by firm2026-08-10
excluded packagepackage23155-11823155-118-01DDiscontinued by firm2026-08-10
excluded packagepackage23155-11823155-118-03DDiscontinued by firm2026-08-10

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage23155-118-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage23155-118-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage23155-118-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage23155-118-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage23155-118-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage23155-118-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage23155-118-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage23155-118-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage23155-118-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage23155-118-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage23155-118-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage23155-118-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage23155-118-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage23155-118-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage23155-118-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage23155-118-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage23155-118-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage23155-118-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage23155-118-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage23155-118-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage23155-118-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage23155-118-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage23155-118-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage23155-118-03557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091174-001CALCITRIOLCALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-24
A091174-002CALCITRIOLCALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091174-001AB
A091174-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091174-001CALCITRIOL0.25MCGCAPSULE / ORALAB2013-05-24782e0a99824c…
2021-12-28 21:50 UTC2021-12A091174-002CALCITRIOL0.5MCGCAPSULE / ORALAB2013-05-24782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091174-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091174-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091174-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091174-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091174-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091174-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091174-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091174-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091174-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091174-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091174-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091174-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091174-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091174-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091174-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091174-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091174-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091174-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091174-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091174-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091174-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091174-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091174-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091174-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091174-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091174-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091174-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091174-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091174-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091174-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091174-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091174-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091174-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091174-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091174-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091174-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091174-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091174-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091174-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091174-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-118-01EA - Each23155-118ab3ffa36-2a08-4934-b234-bc9e2c50b3e612013-06-04
23155-118-03EA - Each23155-1182e4a330c-cb72-4bab-8848-d90c1651623e12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
GELATININACTIVE INGREDIENT2G86QN327LCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ACALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
SORBITANINACTIVE INGREDIENT6O92ICV9RUCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
SORBITOLINACTIVE INGREDIENT506T60A25RCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6
WATERINACTIVE INGREDIENT059QF0KO0RCALCITRIOL CAPSULE, LIQUID FILLED [HERITAGE PHARMACEUTICALS INC]6

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalcitriolCALCITRIOLBryant Ranch Prepackbf621b22-b783-416f-aee3-e0dbfdb782ca2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091174
application number: ANDA091174
CalcitriolCALCITRIOLGolden State Medical Supply, Inc.8465337c-86ca-ea9d-e053-2991aa0ab1672026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091174
application number: ANDA091174
CalcitriolCALCITRIOLBIONPHARMA INC.626f23d5-31e6-41ca-a696-191a4f2bc7ef2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091174
application number: ANDA091174
CalcitriolCALCITRIOLA-S Medication Solutionsb57feb9f-2c5c-4d1c-9330-09c6e9fed95c2023-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091174
application number: ANDA091174
CalcitriolCALCITRIOLAphena Pharma Solutions - Tennessee, LLC3c40c40c-1627-4bcd-ba35-bee9b952d9852023-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091174
application number: ANDA091174

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-118-0123155011801100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (23155-118-01) 2013-05-290000-00-00NoNoCurrent
23155-118-032315501180330 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (23155-118-03) 2013-05-290000-00-00NoNoCurrent