calcipotriene

Product NDC: 66993-878
11-digit product format: 669930878
Labeler code: 66993
Product ID: 66993-878_701245ab-fce0-4a80-90c7-9e3cfa79a9f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: calcipotriene
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Prasco Laboratories
Application: NDA020273
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-07-01
Substance: CALCIPOTRIENE
Active strength: 50 ug/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
N020273-001	DOVONEX	CALCIPOTRIENE	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020273-001	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UTC	2026-02	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020273-001	DOVONEX	0.005%	OINTMENT / TOPICAL		RLD	1993-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020273-001	DOVONEX	0.005%	OINTMENT / TOPICAL		RLD	1993-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	AB	RLD	1993-12-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020273-001	DOVONEX	0.005% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD	1993-12-29	`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	N020273-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020273-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020273-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020273-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020273-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020273-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020273-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020273-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020273-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020273-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020273-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020273-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020273-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020273-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020273-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020273-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020273-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020273-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020273-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020273-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020273-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020273-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020273-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020273-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020273-001	AB	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020273-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCIPOTRIENE	50 ug/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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198373	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
fe7cd92a-f066-4c4a-80c8-e3f929ad4181	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
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
07737a91-49bd-c707-82e4-7a6a1660aef6	Product name	2	20150616
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
66993-878-61	calcipotriene	60 g in 1 TUBE	OINTMENT	60	9
66993-878-61	calcipotriene	1 in 1 CARTON	OINTMENT	1	9
66993-878-78	calcipotriene	120 g in 1 TUBE	OINTMENT	120	9
66993-878-78	calcipotriene	1 in 1 CARTON	OINTMENT	1	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-878-61	GM - Gram	66993-878	52419c27-1157-4352-990d-0843efe06fe3	1	2013-09-04
66993-878-78	GM - Gram	66993-878	8abf4060-2cc7-4fcd-acf1-0ddb4203fd5a	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCIPOTRIENE	ACTIVE INGREDIENT	143NQ3779B	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	2
CALCIPOTRIENE	ACTIVE MOIETY	143NQ3779B	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	2
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-878	CALCIPOTRIENE OINTMENT [PRASCO LABORATORIES]	9	Current NDC, Legacy NDC, 4 package rows	20200813_fe7cd92a-f066-4c4a-80c8-e3f929ad4181.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
calcipotriene	CALCIPOTRIENE	Prasco Laboratories	fe7cd92a-f066-4c4a-80c8-e3f929ad4181	2020-08-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020273 application number: NDA020273 ndc (product): 66993-878

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
143NQ3779B	CALCIPOTRIENE	112965-21-6	CALCIPOTRIENE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198373	calcipotriene 0.005 % Topical Ointment	PSN	fe7cd92a-f066-4c4a-80c8-e3f929ad4181	9
198373	calcipotriene 0.00005 MG/MG Topical Ointment	SCD	fe7cd92a-f066-4c4a-80c8-e3f929ad4181	9
198373	calcipotriene 0.005 % Topical Ointment	SY	fe7cd92a-f066-4c4a-80c8-e3f929ad4181	9
198373	calcipotriene 50 MCG/GM Topical Ointment	SY	fe7cd92a-f066-4c4a-80c8-e3f929ad4181	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-878-61	66993087861	1 TUBE in 1 CARTON (66993-878-61) / 60 g in 1 TUBE	1 tube	2013-07-01	0000-00-00	No	No	Current
66993-878-78	66993087878	1 TUBE in 1 CARTON (66993-878-78) / 120 g in 1 TUBE	1 tube	2013-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
calcipotriene	Prasco Laboratories \| LEO Laboratories Ltd.	2020-08-07	HUMAN PRESCRIPTION DRUG LABEL	9