Calcipotriene

Product NDC
51672-4154
11-digit product format
516724154
Labeler code
51672
Product ID
51672-4154_28f10ac8-a7fd-c5e4-e063-6294a90a2eee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Calcipotriene
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA090633
Marketing category
ANDA
Marketing start
2010-03-24
Substance
CALCIPOTRIENE
Active strength
.05 mg/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
A090633-001CALCIPOTRIENECALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090633-001AB

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 UTC2026-02A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-243f01610625f2…
2019-09-15 20:21 UTC2019-09A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALABRS2010-03-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090633-001CALCIPOTRIENE0.005%OINTMENT / TOPICALRS2010-03-24cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090633-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090633-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090633-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090633-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090633-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090633-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090633-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090633-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090633-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090633-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090633-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090633-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090633-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090633-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090633-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090633-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090633-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090633-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090633-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090633-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090633-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090633-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090633-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090633-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090633-001AB1f41ea6bd6efb…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090633-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Calcipotriene
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIPOTRIENE.05 mg/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
198373Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
277d843a-0ea9-429d-813d-49ed72dafb64Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4154-3Calcipotriene1 in 1 CARTONOINTMENT14
51672-4154-3Calcipotriene60 g in 1 TUBEOINTMENT604
51672-4154-4Calcipotriene1 in 1 CARTONOINTMENT14
51672-4154-4Calcipotriene120 g in 1 TUBEOINTMENT1204
51672-4154-5Calcipotriene10 in 1 CARTONOINTMENT104
51672-4154-5Calcipotriene5 g in 1 TUBEOINTMENT54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4154-3GM - Gram51672-4154ca4aa1e8-238a-4057-bf18-4720d1fb52da12012-07-24
51672-4154-4GM - Gram51672-4154f6c4e694-a5c5-446f-be24-9f63655f2e6b12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4154CALCIPOTRIENE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 6 package rows20241212_277d843a-0ea9-429d-813d-49ed72dafb64.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalcipotrieneCALCIPOTRIENESun Pharmaceutical Industries, Inc.277d843a-0ea9-429d-813d-49ed72dafb642026-07-14Adverse reactionsExact identifier
application applno (ANDA): 090633
application number: ANDA090633
ndc (product): 51672-4154
CalcitreneCALCIPOTRIENESun Pharmaceutical Industries, Inc.94d4f46a-f254-4fe2-b4bd-7a533d6324fe2026-07-14Adverse reactionsExact identifier
application applno (ANDA): 090633
application number: ANDA090633
CalcipotrieneCALCIPOTRIENEGlenmark Pharmaceuticals Inc., USA1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090633
application number: ANDA090633

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198373calcipotriene 0.005 % Topical OintmentPSN277d843a-0ea9-429d-813d-49ed72dafb644
198373calcipotriene 0.00005 MG/MG Topical OintmentSCD277d843a-0ea9-429d-813d-49ed72dafb644
198373calcipotriene 0.005 % Topical OintmentSY277d843a-0ea9-429d-813d-49ed72dafb644
198373calcipotriene 50 MCG/GM Topical OintmentSY277d843a-0ea9-429d-813d-49ed72dafb644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4154-3516724154031 TUBE in 1 CARTON (51672-4154-3) / 60 g in 1 TUBE1 tube2010-03-240000-00-00NoNoCurrent
51672-4154-4516724154041 TUBE in 1 CARTON (51672-4154-4) / 120 g in 1 TUBE1 tube2010-03-240000-00-00NoNoCurrent
51672-4154-55167241540510 TUBE in 1 CARTON (51672-4154-5) / 5 g in 1 TUBE10 tube2010-03-240000-00-00NoNoCurrent