Home NDC 0713-0318 Calcipotriene
Product NDC 0713-0318
11-digit product format 007130318
Labeler code 0713
Product ID 0713-0318_ed81406a-8c10-5c33-e053-2a95a90a941f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcipotriene
Dosage form SOLUTION
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA078468
Marketing category ANDA
Marketing start 2011-03-24
Substance CALCIPOTRIENE
Active strength .05 mg/mL
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 A078468-001 CALCIPOTRIENE CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078468-001 AT
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 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT RS 2011-03-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078468-001 CALCIPOTRIENE 0.005% SOLUTION / TOPICAL AT 2011-03-24 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 .05 mg/mL
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 308865 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 0713-0318-53 Calcipotriene 1 in 1 CARTON SOLUTION 1 10 0713-0318-53 Calcipotriene 60 mL in 1 BOTTLE SOLUTION 60 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Calcipotriene ACTIVE INGREDIENT 143NQ3779B CALCIPOTRIENE (CALCIPOTRIENE) SOLUTION [G&W LABORATORIES, INC.] 3 Calcipotriene ACTIVE MOIETY 143NQ3779B CALCIPOTRIENE (CALCIPOTRIENE) SOLUTION [G&W LABORATORIES, INC.] 3 Hydroxypropyl Cellulose (type H) INACTIVE INGREDIENT RFW2ET671P CALCIPOTRIENE (CALCIPOTRIENE) SOLUTION [G&W LABORATORIES, INC.] 3 Isopropyl Alcohol INACTIVE INGREDIENT ND2M416302 CALCIPOTRIENE (CALCIPOTRIENE) SOLUTION [G&W LABORATORIES, INC.] 3 Menthol INACTIVE INGREDIENT L7T10EIP3A CALCIPOTRIENE (CALCIPOTRIENE) SOLUTION [G&W LABORATORIES, INC.] 3 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 CALCIPOTRIENE (CALCIPOTRIENE) SOLUTION [G&W LABORATORIES, INC.] 3 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR CALCIPOTRIENE (CALCIPOTRIENE) SOLUTION [G&W LABORATORIES, INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R CALCIPOTRIENE (CALCIPOTRIENE) SOLUTION [G&W LABORATORIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0318 CALCIPOTRIENE SOLUTION [COSETTE PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20221116_21378c25-5622-8bf7-1a8c-b05940a846a0.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 0713-0318-53 00713031853 1 BOTTLE in 1 CARTON (0713-0318-53) / 60 mL in 1 BOTTLE 1 bottle 2011-03-24 0000-00-00 No No Current