Home NDC 51407-605-12 calcipotriene
Product NDC 51407-605
Requested package NDC 51407-605-12
11-digit product format 514070605
Labeler code 51407
Product ID 51407-605_f1dae2f4-94e3-2b95-e053-2995a90a377c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcipotriene
Dosage form CREAM
Route TOPICAL
Labeler Golden State Medical Supply, Inc.
Application ANDA205772
Marketing category ANDA
Marketing start 2015-06-09
Marketing end 0000-00-00
Substance CALCIPOTRIENE
Active strength 50 ug/g
Pharmacologic classes Vitamin D Analog [EPC], Vitamin D [CS]
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51407-605-12 51407060512 1 TUBE in 1 CARTON (51407-605-12) > 120 g in 1 TUBE 1 tube 2021-12-09 0000-00-00 No No Current