Home NDC 66993-938 Calcipotriene and Betamethasone Dipropionate
Product NDC 66993-938
11-digit product format 669930938
Labeler code 66993
Product ID 66993-938_aad74639-2667-44ea-9d2b-32a5dd5ea596
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcipotriene and Betamethasone Dipropionate
Dosage form OINTMENT
Route TOPICAL
Labeler Prasco Laboratories
Application NDA021852
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-01-28
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 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…
Additional Listing Data#
Finished product Yes
Brand name base Calcipotriene and Betamethasone Dipropionate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 388525 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66993-938-61 Calcipotriene and Betamethasone Dipropionate 60 g in 1 TUBE OINTMENT 60 5 66993-938-61 Calcipotriene and Betamethasone Dipropionate 1 in 1 CARTON OINTMENT 1 5 66993-938-65 Calcipotriene and Betamethasone Dipropionate 1 in 1 CARTON OINTMENT 1 5 66993-938-65 Calcipotriene and Betamethasone Dipropionate 100 g in 1 TUBE OINTMENT 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-938 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE OINTMENT [PRASCO LABORATORIES] 5 Current NDC, Legacy NDC, 4 package rows 20221213_d9493e66-251c-426c-90a8-1bf1e526ab85.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.
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 66993-938-61 66993093861 1 TUBE in 1 CARTON (66993-938-61) / 60 g in 1 TUBE 1 tube 2020-01-28 0000-00-00 No No Current 66993-938-65 66993093865 1 TUBE in 1 CARTON (66993-938-65) / 100 g in 1 TUBE 1 tube 2020-01-28 0000-00-00 No No Current