Home NDC 16714-763 calcipotriene
Product NDC 16714-763
11-digit product format 167140763
Labeler code 16714
Product ID 16714-763_ee33f5da-8d1a-429e-aa0c-15d19353fc44
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcipotriene
Dosage form CREAM
Route TOPICAL
Labeler Northstar Rx LLC
Application ANDA205772
Marketing category ANDA
Marketing start 2015-06-01
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16714-763-01 calcipotriene 1 in 1 CARTON CREAM 1 4 16714-763-01 calcipotriene 60 g in 1 TUBE CREAM 60 4 16714-763-02 calcipotriene 1 in 1 CARTON CREAM 1 4 16714-763-02 calcipotriene 120 g in 1 TUBE CREAM 120 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-763 CALCIPOTRIENE CREAM [NORTHSTAR RX LLC] 4 Current NDC, Legacy NDC, 4 package rows 20240625_a882ef4f-603e-4421-97ae-2c78822c767a.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 16714-763-01 16714076301 1 TUBE in 1 CARTON (16714-763-01) / 60 g in 1 TUBE 1 tube 2018-05-01 0000-00-00 No No Current 16714-763-02 16714076302 1 TUBE in 1 CARTON (16714-763-02) / 120 g in 1 TUBE 1 tube 2018-05-01 0000-00-00 No No Current