TACLONEX

Product NDC: 50222-501
11-digit product format: 502220501
Labeler code: 50222
Product ID: 50222-501_5d56e57e-6b91-4916-96d8-6dca1af7487d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: calcipotriene and betamethasone dipropionate
Dosage form: SUSPENSION
Route: TOPICAL
Labeler: LEO Pharma Inc.
Application: NDA022185
Marketing category: NDA
Marketing start: 2008-06-01
Substance: BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE
Active strength: .5; 50 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: 2026-12-31
Current FDA listing: Yes

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50222-501	50222-501-51	D	Discontinued by firm		2026-08-03

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 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
N022185-001	TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022185-001	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	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL		RLD, RS	2008-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL		RLD, RS	2008-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL		RLD, RS	2008-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL		RLD, RS	2008-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022185-001	TACLONEX	0.064%;0.005%	SUSPENSION / TOPICAL	AB	RLD, RS	2008-05-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022185-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022185-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022185-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022185-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022185-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022185-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022185-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022185-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022185-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022185-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022185-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022185-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022185-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022185-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022185-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022185-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022185-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022185-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022185-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022185-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022185-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022185-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022185-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022185-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022185-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022185-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022185-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022185-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022185-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022185-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022185-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022185-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022185-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022185-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022185-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022185-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022185-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022185-001	6753013	2020-01-27	U-193	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6753013	2020-01-27	U-88	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6753013	2020-01-27	U-1761	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6787529	2020-01-27	U-193	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6787529	2020-01-27	U-88	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	6787529	2020-01-27	U-1761	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6753013	2020-01-27	U-193	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6753013	2020-01-27	U-88	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6753013	2020-01-27	U-1761	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6787529	2020-01-27	U-88	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6787529	2020-01-27	U-1761	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	6787529	2020-01-27	U-193	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6753013	2020-01-27	U-193	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6753013	2020-01-27	U-88	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6753013	2020-01-27	U-1761	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6787529	2020-01-27	U-88	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6787529	2020-01-27	U-1761	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	6787529	2020-01-27	U-193	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6753013	2020-01-27	U-193	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6753013	2020-01-27	U-88	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6753013	2020-01-27	U-1761	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6787529	2020-01-27	U-193	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6787529	2020-01-27	U-88	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	6787529	2020-01-27	U-1761	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6753013	2020-01-27	U-193	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6753013	2020-01-27	U-88	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6753013	2020-01-27	U-1761	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6787529	2020-01-27	U-193	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6787529	2020-01-27	U-88	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	6787529	2020-01-27	U-1761	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6753013	2020-01-27	U-193	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6753013	2020-01-27	U-1761	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6753013	2020-01-27	U-88	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6787529	2020-01-27	U-1761	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6787529	2020-01-27	U-193	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022185-001	6787529	2020-01-27	U-88	Drug product	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022185-001	NPP	2022-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022185-001	PED	2023-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022185-001	NPP	2022-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022185-001	PED	2023-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022185-001	NPP	2022-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022185-001	PED	2023-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022185-001	NPP	2022-07-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022185-001	PED	2023-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022185-001	NPP	2022-07-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022185-001	PED	2023-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022185-001	NPP	2022-07-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022185-001	PED	2023-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022185-001	NPP	2022-07-25	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022185-001	PED	2023-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022185-001	NPP	2022-07-25	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022185-001	PED	2023-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022185-001	NPP	2022-07-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022185-001	PED	2023-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022185-001	NPP	2022-07-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022185-001	PED	2023-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022185-001	NPP	2022-07-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022185-001	PED	2023-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022185-001	NPP	2022-07-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022185-001	PED	2023-01-25	`b00525d2431f…`
2023-12-20 04:57 UTC	2023-12	N022185-001	PED	2023-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022185-001	PED	2023-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022185-001	PED	2023-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022185-001	PED	2023-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022185-001	PED	2023-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022185-001	PED	2023-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022185-001	NPP	2022-07-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022185-001	PED	2023-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022185-001	NPP	2022-07-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022185-001	PED	2023-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022185-001	NPP	2022-07-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022185-001	PED	2023-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022185-001	NPP	2022-07-25	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022185-001	PED	2023-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022185-001	NPP	2022-07-25	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022185-001	PED	2023-01-25	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: TACLONEX
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIPOTRIENE HYDRATE	.5 mg/g
BETAMETHASONE DIPROPIONATE	50 ug/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
S7499TYY6G	Internal UNII lookup
826Y60901U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
833461	Internal RxNorm lookup
833463	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
757c914f-dd8d-43cc-a973-212d591af4af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dde7b902-54a1-627e-12f1-9e6d244ab88c	Product name	4	20250317
69b49899-11cf-4f7e-bd0a-7dc93b27311b	Product name	3	20250130
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
0a2fcc35-464b-9ec2-a622-753662cdd48c	Product name	3	20240216
6f762601-17ef-4321-8f47-77783d3c4d8b	Product name	3	20231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70	Product name	5	20220921
4d1338f1-f50a-5bb5-4946-11534fdee48f	Product name	2	20210527
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
c148aeb5-688c-9b49-a40f-30a41e3595e4	Product name	2	20180419
4ea9e4b5-b452-48ad-9b25-b9a4d403405d	Product name	1	20160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
07737a91-49bd-c707-82e4-7a6a1660aef6	Product name	2	20150616
4f07db9b-3707-3e2c-05b5-d7852ba808c4	Product name	1	20140508
6f16fc1e-e77d-460f-8810-a12ca121425c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50222-501-06	TACLONEX	1 in 1 CARTON	SUSPENSION	1	25
50222-501-06	TACLONEX	40 in 1 CASE	SUSPENSION	40	25
50222-501-51	TACLONEX	1 in 1 CARTON	SUSPENSION	1	25
50222-501-51	TACLONEX	40 in 1 CASE	SUSPENSION	40	25
50222-501-66	TACLONEX	2 in 1 PACKAGE	SUSPENSION	2	25
50222-501-66	TACLONEX	10 in 1 BOX	SUSPENSION	10	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50222-501-06	GM - Gram	50222-501	e8781476-328d-4898-82c6-b53864abfb87	1	2012-07-24
50222-501-66	GM - Gram	50222-501	97ca081c-0aea-4e6e-8d56-a480ae25d1ed	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BETAMETHASONE DIPROPIONATE	ACTIVE INGREDIENT	826Y60901U	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	15
CALCIPOTRIENE HYDRATE	ACTIVE INGREDIENT	S7499TYY6G	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	15
BETAMETHASONE	ACTIVE MOIETY	9842X06Q6M	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	15
CALCIPOTRIENE	ACTIVE MOIETY	143NQ3779B	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	15
.ALPHA.-TOCOPHEROL, DL-	INACTIVE INGREDIENT	7QWA1RIO01	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	15
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	15
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	15
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	15
PPG-11 STEARYL ETHER	INACTIVE INGREDIENT	S4G2J0Y0LG	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	15
BETAMETHASONE DIPROPIONATE	ACTIVE INGREDIENT	826Y60901U	TACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
CALCIPOTRIENE	ACTIVE INGREDIENT	143NQ3779B	TACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
BETAMETHASONE	ACTIVE MOIETY	9842X06Q6M	TACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
CALCIPOTRIENE	ACTIVE MOIETY	143NQ3779B	TACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	TACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	TACLONEX SCALP (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50222-501	TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) SUSPENSION [LEO PHARMA INC.]	25	Current NDC, Legacy NDC, 6 package rows	20210703_757c914f-dd8d-43cc-a973-212d591af4af.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TACLONEX	CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	LEO Pharma Inc.	757c914f-dd8d-43cc-a973-212d591af4af	2017-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022185 application number: NDA022185 ndc (product): 50222-501

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
826Y60901U	BETAMETHASONE DIPROPIONATE	5593-20-4	BETAMETHASONE DIPROPIONATE
S7499TYY6G	CALCIPOTRIENE HYDRATE	147657-22-5	CALCIPOTRIENE HYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
833461	calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical Suspension	PSN	757c914f-dd8d-43cc-a973-212d591af4af	25
833463	Taclonex Scalp (calcipotriene 0.005 % / betamethasone dipropionate 0.064 % ) Topical Suspension	PSN	757c914f-dd8d-43cc-a973-212d591af4af	25
833463	betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical Lotion [Taclonex]	SBD	757c914f-dd8d-43cc-a973-212d591af4af	25
833461	betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical Lotion	SCD	757c914f-dd8d-43cc-a973-212d591af4af	25
833461	betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical Suspension	SY	757c914f-dd8d-43cc-a973-212d591af4af	25
833463	Taclonex Scalp (calcipotriene 0.005 % / betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) ) Topical Suspension	SY	757c914f-dd8d-43cc-a973-212d591af4af	25
833461	calcipotriene 0.005 % / betamethasone dipropionate 0.064 % Topical Suspension	PSN	d61c7acb-a64f-46ee-b125-0c80d3b35585	1
833463	Taclonex Scalp (calcipotriene 0.005 % / betamethasone dipropionate 0.064 % ) Topical Suspension	PSN	d61c7acb-a64f-46ee-b125-0c80d3b35585	1
833463	betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical Lotion [Taclonex]	SBD	d61c7acb-a64f-46ee-b125-0c80d3b35585	1
833461	betamethasone 0.5 MG/ML / calcipotriene 0.05 MG/ML Topical Lotion	SCD	d61c7acb-a64f-46ee-b125-0c80d3b35585	1
833461	betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / calcipotriene 0.005 % Topical Suspension	SY	d61c7acb-a64f-46ee-b125-0c80d3b35585	1
833463	Taclonex Scalp (calcipotriene 0.005 % / betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) ) Topical Suspension	SY	d61c7acb-a64f-46ee-b125-0c80d3b35585	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50222-501-06	50222050106	40 CARTON in 1 CASE (50222-501-06) / 1 BOTTLE in 1 CARTON / 60 g in 1 BOTTLE	40 carton	2008-06-01	0000-00-00	No	No	Current
50222-501-51	50222050151	40 CARTON in 1 CASE (50222-501-51) > 1 BOTTLE in 1 CARTON > 4 g in 1 BOTTLE	40 carton	2008-06-01	0000-00-00	No	No	Current
50222-501-66	50222050166	10 PACKAGE in 1 BOX (50222-501-66) / 2 BOTTLE in 1 PACKAGE / 60 g in 1 BOTTLE	10 package	2008-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TACLONEX	LEO Pharma Inc. \| LEO Laboratories Ltd.	2017-11-30	HUMAN PRESCRIPTION DRUG LABEL	25
Taclonex Scalp	Physicians Total Care, Inc.	2010-08-18	HUMAN PRESCRIPTION DRUG LABEL	1