Home NDC 68462-310 Calcipotriene
Product NDC 68462-310
11-digit product format 684620310
Labeler code 68462
Product ID 68462-310_a281edd2-1ec3-440c-9823-1c7541ff8c83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcipotriene
Dosage form OINTMENT
Route TOPICAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA090633
Marketing category ANDA
Marketing start 2010-03-24
Substance CALCIPOTRIENE
Active strength 50 ug/g
Pharmacologic classes Vitamin D Analog [EPC], Vitamin D [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A090633-001 CALCIPOTRIENE CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090633-001 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 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL AB RS 2010-03-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090633-001 CALCIPOTRIENE 0.005% OINTMENT / TOPICAL RS 2010-03-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Calcipotriene
Listing expiration 2027-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-310-65 Calcipotriene 60 g in 1 TUBE OINTMENT 60 9 68462-310-66 Calcipotriene 120 g in 1 TUBE OINTMENT 120 9 68462-310-66 Calcipotriene 1 in 1 CARTON OINTMENT 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALCIPOTRIENE ACTIVE INGREDIENT 143NQ3779B CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3 CALCIPOTRIENE ACTIVE MOIETY 143NQ3779B CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3 SODIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT 94255I6E2T CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3 STEARETH-2 INACTIVE INGREDIENT V56DFE46J5 CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3 WATER INACTIVE INGREDIENT 059QF0KO0R CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-310 CALCIPOTRIENE OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] 8 Current NDC, Legacy NDC, 3 package rows 20240104_1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc.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 · 3 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 68462-310-65 68462031065 60 g in 1 TUBE (68462-310-65) 60 g 2010-03-24 0000-00-00 No No Current 68462-310-66 68462031066 1 TUBE in 1 CARTON (68462-310-66) / 120 g in 1 TUBE 1 tube 2010-03-24 0000-00-00 No No Current