Home NDC 50222-302 ENSTILAR
Product NDC 50222-302
11-digit product format 502220302
Labeler code 50222
Product ID 50222-302_0b771976-2050-4eef-bc39-3c853c7c0ac2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcipotriene and betamethasone dipropionate
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler LEO Pharma Inc.
Application NDA207589
Marketing category NDA
Marketing start 2015-10-16
Substance BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE MONOHYDRATE
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 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 N207589-001 ENSTILAR BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207589-001 10130640 2031-06-10 Drug product 2018-12-06 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 N207589-001 9119781 2031-06-10 U-2627 Drug product 2015-11-12 N207589-001 9566286 2031-06-10 Drug product 2019-11-15 N207589-001 10130640*PED 2031-12-10 Pediatric extension N207589-001 9119781*PED 2031-12-10 Pediatric extension
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 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL AB RLD, RS 2015-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207589-001 ENSTILAR 0.064%;0.005% AEROSOL, FOAM / TOPICAL RLD, RS 2015-10-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 11 · 434 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207589-001 10130640 2031-06-10 Drug product 2018-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 9119781 2031-06-10 U-2627 Drug product 2015-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 9566286 2031-06-10 Drug product 2019-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 10130640*PED 2031-12-10 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207589-001 9119781*PED 2031-12-10 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10130640 2031-06-10 Drug product 2018-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 9119781 2031-06-10 U-2627 Drug product 2015-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 9566286 2031-06-10 Drug product 2019-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 10130640*PED 2031-12-10 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207589-001 9119781*PED 2031-12-10 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207589-001 10130640 2031-06-10 Drug product 2018-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 9119781 2031-06-10 U-2627 Drug product 2015-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 9566286 2031-06-10 Drug product 2019-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 10130640*PED 2031-12-10 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207589-001 9119781*PED 2031-12-10 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10130640 2031-06-10 Drug product 2018-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10617698 2031-06-10 Drug product 2020-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10660908 2031-06-10 U-2627 Drug product 2020-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10682364 2031-06-10 Drug product 2020-07-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10688108 2031-06-10 U-2627 2020-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 10716799 2031-06-10 Drug product 2020-08-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207589-001 9119781 2031-06-10 U-1761 Drug product 2015-11-12 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base ENSTILAR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIPOTRIENE MONOHYDRATE .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 1716094 Internal RxNorm lookup 1716099 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BETAMETHASONE DIPROPIONATE ACTIVE INGREDIENT 826Y60901U ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 CALCIPOTRIENE HYDRATE ACTIVE INGREDIENT S7499TYY6G ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 BETAMETHASONE ACTIVE MOIETY 9842X06Q6M ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 CALCIPOTRIENE ACTIVE MOIETY 143NQ3779B ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 ALPHA-TOCOPHEROL, DL- INACTIVE INGREDIENT 7QWA1RIO01 ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 BUTANE INACTIVE INGREDIENT 6LV4FOR43R ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 DIMETHYL ETHER INACTIVE INGREDIENT AM13FS69BX ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2 PPG-11 STEARYL ETHER INACTIVE INGREDIENT S4G2J0Y0LG ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50222-302 ENSTILAR (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) AEROSOL, FOAM [LEO PHARMA INC.] 15 Current NDC, Legacy NDC, 6 package rows 20220607_d1193df2-d53f-4342-bd9d-d9cba7c89709.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 ENSTILAR CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE LEO Pharma Inc. d1193df2-d53f-4342-bd9d-d9cba7c89709 2021-10-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 207589 application number: NDA207589 ndc (product): 50222-302
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 50222-302-60 50222030260 1 CAN in 1 CARTON (50222-302-60) / 60 g in 1 CAN 1 can 2015-10-16 0000-00-00 No No Current 50222-302-66 50222030266 2 CAN in 1 CARTON (50222-302-66) / 60 g in 1 CAN 2 can 2015-10-16 0000-00-00 No No Current 50222-302-91 50222030291 1 CAN in 1 CARTON (50222-302-91) / 60 g in 1 CAN 1 can 2015-10-16 0000-00-00 Yes No Current