Home NDC 73499-001 Wynzora
Product NDC 73499-001
11-digit product format 734990001
Labeler code 73499
Product ID 73499-001_22617d3b-9736-472b-bc08-1ce53fe151aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcipotriene and Betamethasone dipropionate
Dosage form CREAM
Route TOPICAL
Labeler MC2 Therapeutics Ltd
Application NDA213422
Marketing category NDA
Marketing start 2021-06-30
Substance CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE
Active strength 50; 64 ug/g; mg/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 43 .
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 N213422-001 WYNZORA BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213422-001 10265265 2027-09-27 Drug product 2020-08-27 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13
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.
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 2026-09-14 22:38:34 2026-08 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213422-001 WYNZORA 0.064%;0.005% CREAM / TOPICAL RLD, RS 2020-07-20 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 67 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213422-001 12440499 2039-03-18 U-1408 Drug product 2025-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213422-001 11696919 2039-03-18 Drug product 2023-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213422-001 10265265 2027-09-27 Drug product 2020-08-27 bb7c543d1eb4…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Wynzora
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIPOTRIENE 50 ug/g BETAMETHASONE DIPROPIONATE 64 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 143NQ3779B 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 2471873 Internal RxNorm lookup 2471878 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73499-001 WYNZORA (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) CREAM [MC2 THERAPEUTICS LTD] 6 Current NDC, Legacy NDC, 4 package rows 20231207_36c5c818-0d40-445e-a3c0-0f46723a25e2.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 Wynzora CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE MC2 Therapeutics Ltd 36c5c818-0d40-445e-a3c0-0f46723a25e2 2023-11-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 213422 application number: NDA213422 ndc (product): 73499-001
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 73499-001-01 73499000101 1 TUBE in 1 CARTON (73499-001-01) / 60 g in 1 TUBE 1 tube 2021-06-30 0000-00-00 No No Current 73499-001-03 73499000103 10 TUBE in 1 CARTON (73499-001-03) / 5 g in 1 TUBE 10 tube 2021-06-30 0000-00-00 Yes No Current