Home NDC 45802-989-01 Calcipotriene and Betamethasone Dipropionate
Product NDC 45802-989
Requested package NDC 45802-989-01
11-digit product format 458020989
Labeler code 45802
Product ID 45802-989_bd8b177b-ef44-4f19-9aa9-6d5c6a6164a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcipotriene and betamethasone dipropionate
Dosage form OINTMENT
Route TOPICAL
Labeler Perrigo New York Inc
Application NDA021852
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2008-06-01
Marketing end 0000-00-00
Substance CALCIPOTRIENE HYDRATE; BETAMETHASONE DIPROPIONATE
Active strength 50 ug/g; mg/g
Pharmacologic classes Vitamin D [CS],Vitamin D Analog [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021852-001 TACLONEX BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021852-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021852-001 TACLONEX 0.064%;0.005% OINTMENT / TOPICAL AB RLD, RS 2006-01-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021852-001 6753013 2020-01-27 U-193 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021852-001 6753013 2020-01-27 U-88 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021852-001 6753013 2020-01-27 U-193 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021852-001 6753013 2020-01-27 U-88 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021852-001 6753013 2020-01-27 U-193 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021852-001 6753013 2020-01-27 U-88 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021852-001 6753013 2020-01-27 U-193 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021852-001 6753013 2020-01-27 U-88 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021852-001 6753013 2020-01-27 U-193 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021852-001 6753013 2020-01-27 U-88 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021852-001 6753013 2020-01-27 U-88 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021852-001 6753013 2020-01-27 U-193 Drug product ea99ee380514…
DailyMed Socrata Ingredients# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45802-989-01 45802098901 1 TUBE in 1 CARTON (45802-989-01) > 100 g in 1 TUBE 1 tube 2008-06-01 0000-00-00 No No Current