Home NDC 50222-227 Taclonex
Product NDC 50222-227
11-digit product format 502220227
Labeler code 50222
Product ID 50222-227_cb1fa930-78f8-427b-bdcb-8072055bd2bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcipotriene and betamethasone dipropionate
Dosage form OINTMENT
Route TOPICAL
Labeler LEO Pharma Inc.
Application NDA021852
Marketing category NDA
Marketing start 2008-06-01
Marketing end 0000-00-00
Substance BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE
Active strength 1 mg/g; ug/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Vitamin D Analog [EPC], Vitamin D [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BETAMETHASONE DIPROPIONATE ACTIVE INGREDIENT 826Y60901U TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [LEO PHARMA INC.] 7 CALCIPOTRIENE HYDRATE ACTIVE INGREDIENT S7499TYY6G TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [LEO PHARMA INC.] 7 BETAMETHASONE ACTIVE MOIETY 9842X06Q6M TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [LEO PHARMA INC.] 7 CALCIPOTRIENE ACTIVE MOIETY 143NQ3779B TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [LEO PHARMA INC.] 7 ALPHA-TOCOPHEROL, DL- INACTIVE INGREDIENT 7QWA1RIO01 TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [LEO PHARMA INC.] 7 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [LEO PHARMA INC.] 7 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [LEO PHARMA INC.] 7 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [LEO PHARMA INC.] 7 PPG-11 STEARYL ETHER INACTIVE INGREDIENT S4G2J0Y0LG TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [LEO PHARMA INC.] 7 BETAMETHASONE DIPROPIONATE ACTIVE INGREDIENT 826Y60901U TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.] 4 CALCIPOTRIENE HYDRATE ACTIVE INGREDIENT S7499TYY6G TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.] 4 BETAMETHASONE ACTIVE MOIETY 9842X06Q6M TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.] 4 CALCIPOTRIENE ACTIVE MOIETY 143NQ3779B TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.] 4 ALPHA-TOCOPHEROL, DL- INACTIVE INGREDIENT 7QWA1RIO01 TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.] 4 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.] 4 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) OINTMENT [PHYSICIANS TOTAL CARE, INC.] 4
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.
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 50222-227-04 50222022704 1 TUBE in 1 CARTON (50222-227-04) > 60 g in 1 TUBE 1 tube 2008-06-01 0000-00-00 No No Current 50222-227-81 50222022781 1 TUBE in 1 CARTON (50222-227-81) > 100 g in 1 TUBE 1 tube 2008-06-01 2022-10-31 No No Current