Home NDC 68462-501 calcipotriene
Product NDC 68462-501
11-digit product format 684620501
Labeler code 68462
Product ID 68462-501_d0707037-c9cd-4c52-a1f5-4c8f72f62010
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcipotriene
Dosage form CREAM
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc.,USA
Application ANDA205772
Marketing category ANDA
Marketing start 2015-06-10
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 A205772-001 CALCIPOTRIENE CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205772-001 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 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205772-001 CALCIPOTRIENE 0.005% CREAM / TOPICAL AB 2015-06-09 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 313921 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIPOTRIENE ACTIVE INGREDIENT 143NQ3779B CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 CALCIPOTRIENE ACTIVE MOIETY 143NQ3779B CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 CETETH-20 INACTIVE INGREDIENT I835H2IHHX CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-501 TRIONEX (CALCIPOTRIENE CREAM, 0.005% AND TRANSPARENT DRESSING) KIT [V2 PHARMA, LLC] 10 Current NDC, Legacy NDC 20230209_45ac2edf-7ed1-4862-888a-f9dd349f1930.zip 68462-501 CALCIPOTRIENE CREAM [GLENMARK PHARMACEUTICALS INC.,USA] 6 Current NDC, Legacy NDC, 4 package rows 20230427_7ec750f6-26ea-46bc-aa7b-174fd25253a2.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 · 2 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 68462-501-65 68462050165 1 TUBE in 1 CARTON (68462-501-65) / 60 g in 1 TUBE 1 tube 2015-06-10 0000-00-00 No No Current 68462-501-66 68462050166 1 TUBE in 1 CARTON (68462-501-66) / 120 g in 1 TUBE 1 tube 2015-06-10 0000-00-00 No No Current