Calcipotriene

Product NDC
66993-877
11-digit product format
669930877
Labeler code
66993
Product ID
66993-877_3682f2c5-9bce-4b4a-a4d6-9af29f08ad63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene
Dosage form
CREAM
Route
TOPICAL
Labeler
Prasco Laboratories
Application
NDA020554
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1996-10-01
Substance
CALCIPOTRIENE
Active strength
50 ug/g
Pharmacologic classes
Vitamin D Analog [EPC], Vitamin D [CS]
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
N020554-001DOVONEXCALCIPOTRIENE0.005%CREAM / TOPICALABRLD, RS1996-07-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020554-001AB

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 UTC2026-02N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-223f01610625f2…
2019-09-15 20:21 UTC2019-09N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020554-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020554-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020554-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020554-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020554-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020554-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020554-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020554-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020554-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020554-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020554-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020554-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020554-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020554-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020554-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020554-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020554-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020554-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020554-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020554-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020554-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020554-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020554-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020554-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020554-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020554-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020554-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020554-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020554-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020554-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020554-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020554-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020554-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020554-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020554-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020554-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020554-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020554-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020554-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020554-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIPOTRIENE50 ug/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
143NQ3779BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313921Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
377eafda-737c-4ba2-9ec5-61209b8814edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-877-61Calcipotriene1 in 1 CARTONCREAM110
66993-877-61Calcipotriene60 g in 1 TUBECREAM6010
66993-877-78Calcipotriene120 g in 1 TUBECREAM12010
66993-877-78Calcipotriene1 in 1 CARTONCREAM110
66993-877-61NuDermRxPAK 601 in 1 CARTONCREAM50 ug in 1g2
66993-877-61NuDermRxPAK 6060 g in 1 TUBECREAM60 g50 ug in 1g2
66993-877-78NuDermRxPAK 1201 in 1 CARTONCREAM50 ug in 1g2
66993-877-78NuDermRxPAK 120120 g in 1 TUBECREAM120 g50 ug in 1g2
66993-877-61NuDermRxPAK 6060 g in 1 TUBECREAM60 g50 ug in 1g1
66993-877-78NuDermRxPAK 120120 g in 1 TUBECREAM120 g50 ug in 1g1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-877-61GM - Gram66993-87701e3dce0-cd1c-4456-b145-3949f62c449112013-02-13
66993-877-78GM - Gram66993-87751370a47-3635-4678-82be-6599528acc5c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIPOTRIENEACTIVE INGREDIENT143NQ3779BCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
CALCIPOTRIENEACTIVE MOIETY143NQ3779BCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
ALPHA-TOCOPHEROL, DL-INACTIVE INGREDIENT7QWA1RIO01CALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
CETETH-20INACTIVE INGREDIENTI835H2IHHXCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
DICHLOROBENZYL ALCOHOLINACTIVE INGREDIENT1NKX3648J9CALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74CALCIPOTRIENE CREAM [PRASCO LABORATORIES]2
WATERINACTIVE INGREDIENT059QF0KO0RCALCIPOTRIENE CREAM [PRASCO LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-877CALCIPOTRIENE CREAM [PRASCO LABORATORIES]10Current NDC, Legacy NDC, 4 package rows20221213_377eafda-737c-4ba2-9ec5-61209b8814ed.zip
66993-877NUDERMRXPAK 120 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC20210506_a838204b-9564-9aa6-e053-2a95a90af02f.zip
66993-877NUDERMRXPAK 60 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC20210511_a837f13e-fafc-0535-e053-2995a90a5070.zip
66993-877NUDERMRXPAK 120 (DIMETHICONE, CALCIPOTRIENE) KIT [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC20190529_89f6689b-ef95-613b-e053-2a95a90ac161.zip
66993-877NUDERMRXPAK 60 (DIMETHICONE, CALCIPOTRIENE) KIT [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC20190525_89a98b7c-d36b-6016-e053-2a95a90aa31b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalcipotrieneCALCIPOTRIENEPrasco Laboratories377eafda-737c-4ba2-9ec5-61209b8814ed2022-12-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 020554
application number: NDA020554
ndc (product): 66993-877

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313921calcipotriene 0.005 % Topical CreamPSN377eafda-737c-4ba2-9ec5-61209b8814ed10
313921calcipotriene 0.05 MG/ML Topical CreamSCD377eafda-737c-4ba2-9ec5-61209b8814ed10
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSY377eafda-737c-4ba2-9ec5-61209b8814ed10
313921calcipotriene 0.005 % Topical CreamSY377eafda-737c-4ba2-9ec5-61209b8814ed10
313921calcipotriene 0.005 % Topical CreamPSNa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene 0.005 % Topical CreamPSNa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.05 MG/ML Topical CreamSCDa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene 0.05 MG/ML Topical CreamSCDa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.005 % Topical CreamSYa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.005 % Topical CreamPSN89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene 0.005 % Topical CreamPSN89f6689b-ef95-613b-e053-2a95a90ac1611
259090dimethicone 5 % Topical CreamPSN89f6689b-ef95-613b-e053-2a95a90ac1611
259090dimethicone 5 % Topical CreamPSN89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene 0.05 MG/ML Topical CreamSCD89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene 0.05 MG/ML Topical CreamSCD89f6689b-ef95-613b-e053-2a95a90ac1611
259090dimethicone 50 MG/ML Topical CreamSCD89a98b7c-d36b-6016-e053-2a95a90aa31b1
259090dimethicone 50 MG/ML Topical CreamSCD89f6689b-ef95-613b-e053-2a95a90ac1611
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSY89a98b7c-d36b-6016-e053-2a95a90aa31b1
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSY89f6689b-ef95-613b-e053-2a95a90ac1611
313921calcipotriene 0.005 % Topical CreamSY89f6689b-ef95-613b-e053-2a95a90ac1611
313921calcipotriene 0.005 % Topical CreamSY89a98b7c-d36b-6016-e053-2a95a90aa31b1
259090dimethicone 5 % Topical CreamSY89f6689b-ef95-613b-e053-2a95a90ac1611
259090dimethicone 5 % Topical CreamSY89a98b7c-d36b-6016-e053-2a95a90aa31b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-877-61669930877611 TUBE in 1 CARTON (66993-877-61) / 60 g in 1 TUBE1 tube1996-10-010000-00-00NoNoCurrent
66993-877-78669930877781 TUBE in 1 CARTON (66993-877-78) / 120 g in 1 TUBE1 tube1996-10-010000-00-00NoNoCurrent