calcitriol

Product NDC
45802-608
11-digit product format
458020608
Labeler code
45802
Product ID
45802-608_d1600f2d-9c61-486e-9ef0-54160ef6adc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
calcitriol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
NDA022087
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-03-08
Substance
CALCITRIOL
Active strength
3 ug/g
Pharmacologic classes
Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022087-001VECTICALCALCITRIOL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-233f01610625f2…
2019-09-15 20:21 UTC2019-09N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022087-001VECTICAL3MCG/GMOINTMENT / TOPICALRLD, RS2009-01-23cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022087-001NPP2023-07-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022087-001NPP2023-07-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022087-001NPP2023-07-174b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022087-001NPP2023-07-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022087-001NPP2023-07-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022087-001NPP2023-07-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N022087-001NPP2023-07-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022087-001NPP2023-07-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022087-001NPP2023-07-17c0c555d07b60…
2023-12-20 04:57 UTC2023-12N022087-001NPP2023-07-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022087-001NPP2023-07-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022087-001NPP2023-07-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022087-001NPP2023-07-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022087-001NPP2023-07-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N022087-001NPP2023-07-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N022087-001NPP2023-07-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022087-001NPP2023-07-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022087-001NPP2023-07-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022087-001NPP2023-07-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022087-001NPP2023-07-17cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
calcitriol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCITRIOL3 ug/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FXC9231JVHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
388517Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7fa4ab07-3d8e-4300-91f3-b1e17cba8691Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
09b728d3-9521-67a6-95fe-30969d1d5187Product name520240828
5f07db61-095c-acca-e8e9-d0916b4c1947Product name220200616
98f556da-44be-c658-496e-47884da4e67bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-608-01calcitriol100 g in 1 TUBEOINTMENT1007
45802-608-01calcitriol1 in 1 CARTONOINTMENT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-608-01GM - Gram45802-6085a018c3d-5a3d-4999-b5be-8b24905c218a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCITRIOLACTIVE INGREDIENTFXC9231JVHCALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3
CALCITRIOLACTIVE MOIETYFXC9231JVHCALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3
.ALPHA.-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01CALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCALCITRIOL OINTMENT [PERRIGO NEW YORK INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-608CALCITRIOL OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 2 package rows20230306_7fa4ab07-3d8e-4300-91f3-b1e17cba8691.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VecticalCALCITRIOLGalderma Laboratories, L.P.a1567da9-af74-4afd-9ac5-8b53ec5d7cbf2024-10-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 022087
application number: NDA022087
calcitriolCALCITRIOLPadagis Israel Pharmaceuticals Ltd7fa4ab07-3d8e-4300-91f3-b1e17cba86912023-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 022087
application number: NDA022087
ndc (product): 45802-608

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388517calcitriol 0.0003 % Topical OintmentPSN7fa4ab07-3d8e-4300-91f3-b1e17cba86917
388517calcitriol 0.000003 MG/MG Topical OintmentSCD7fa4ab07-3d8e-4300-91f3-b1e17cba86917
388517calcitriol 0.0003 % Topical OintmentSY7fa4ab07-3d8e-4300-91f3-b1e17cba86917
388517calcitriol 3 MCG/GM Topical OintmentSY7fa4ab07-3d8e-4300-91f3-b1e17cba86917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-608-01458020608011 TUBE in 1 CARTON (45802-608-01) / 100 g in 1 TUBE1 tube2012-03-080000-00-00NoNoCurrent