Home NDC 51672-5278 Calcitrene
Product NDC 51672-5278
11-digit product format 516725278
Labeler code 51672
Product ID 51672-5278_5d928da9-5181-4a23-a067-27b596d7136a
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090633-001 CALCIPOTRIENE CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090633-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Calcitrene
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIPOTRIENE .05 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 143NQ3779B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198373 Internal RxNorm lookup 1013636 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Calcipotriene ACTIVE INGREDIENT 143NQ3779B CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 Calcipotriene ACTIVE MOIETY 143NQ3779B CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 .alpha.-tocopherol INACTIVE INGREDIENT H4N855PNZ1 CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 mineral oil INACTIVE INGREDIENT T5L8T28FGP CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 petrolatum INACTIVE INGREDIENT 4T6H12BN9U CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium phosphate, dibasic, dihydrate INACTIVE INGREDIENT 94255I6E2T CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 steareth-2 INACTIVE INGREDIENT V56DFE46J5 CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-5278 CALCITRENE (CALCIPOTRIENE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 Current NDC, Legacy NDC, 6 package rows 20190208_94d4f46a-f254-4fe2-b4bd-7a533d6324fe.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-5278-3 51672527803 1 TUBE in 1 CARTON (51672-5278-3) / 60 g in 1 TUBE 1 tube 2010-03-24 0000-00-00 No No Current 51672-5278-4 51672527804 1 TUBE in 1 CARTON (51672-5278-4) / 120 g in 1 TUBE 1 tube 2010-03-24 0000-00-00 No No Current 51672-5278-5 51672527805 10 TUBE in 1 CARTON (51672-5278-5) / 5 g in 1 TUBE 10 tube 2010-03-24 0000-00-00 No No Current