Home NDC 63646-040 calcipotriene and betamethasone dipropionate
Product NDC 63646-040
11-digit product format 636460040
Labeler code 63646
Product ID 63646-040_ca89ea13-a8e1-48bb-ab0a-085891d272bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcipotriene and betamethasone dipropionate
Dosage form SUSPENSION
Route TOPICAL
Labeler TOLMAR Inc.
Application ANDA210765
Marketing category ANDA
Marketing start 2020-05-11
Marketing end 0000-00-00
Substance BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Active strength 1 mg/g; ug/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Vitamin D [CS],Vitamin D Analog [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210765-001 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.
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 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210765-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-05-11 a50c72e98297…
Observed Orange Book normalized TE history# 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 63646-040-12 63646004012 2 BOTTLE in 1 CARTON (63646-040-12) > 60 g in 1 BOTTLE 2 bottle 2020-05-11 0000-00-00 No No Current 63646-040-60 63646004060 1 BOTTLE in 1 CARTON (63646-040-60) > 60 g in 1 BOTTLE 1 bottle 2020-05-11 0000-00-00 No No Current