NuDermRxPAK 60

Product NDC
70859-055
Requested package NDC
70859-055-01
11-digit product format
708590055
Labeler code
70859
Product ID
70859-055_c1752d5a-76cf-73fe-e053-2a95a90a70a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene, Dimethicone
Dosage form
KIT
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA020554
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1996-10-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70859-05570859-055-01IInactivated by FDA2026-08-17

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020554-001DOVONEX0.005%CREAM / TOPICALABRLD, RS1996-07-22caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020554-001AB1caaa826d4ba7…
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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70859-055-012023-01-30C16284748780-1f386c64a-0466-0266-e053-dadaa90a7c1aa837f13e-fafc-0535-e053-2995a90a5070

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66993-877-61NuDermRxPAK 601 in 1 CARTONCREAM50 ug in 1g2
66993-877-61NuDermRxPAK 6060 g in 1 TUBECREAM60 g50 ug in 1g2
68599-0213-4NuDermRxPAK 60118 mg in 1 BOTTLECREAM118 mg50 ug in 1mg2
70859-055-01NuDermRxPAK 601 in 1 KITKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70859-055-01EA - Each70859-0559d18a9d1-2be8-4834-bd40-3001fa0d740a12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70859-055NUDERMRXPAK 60 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 4 package rows20210511_a837f13e-fafc-0535-e053-2995a90a5070.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313921calcipotriene 0.005 % Topical CreamPSNa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.05 MG/ML Topical CreamSCDa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70859-055-01708590055011 KIT in 1 KIT (70859-055-01) * 1 TUBE in 1 CARTON (66993-877-61) > 60 g in 1 TUBE * 118 mg in 1 BOTTLE (68599-0213-4) 1 kit2020-06-160000-00-00NoNoCurrent