Home NDC 45802-816 Calcipotriene and Betamethasone Dipropionate
Product NDC 45802-816
11-digit product format 458020816
Labeler code 45802
Product ID 45802-816_9b7de25a-99a2-4123-b913-ba33289ff5be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcipotriene, Betamethasone Dipropionate
Dosage form OINTMENT
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA200174
Marketing category ANDA
Marketing start 2020-01-30
Substance BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Active strength .643; 50 mg/g; ug/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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 42 .
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 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200174-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200174-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% OINTMENT / TOPICAL AB 2014-12-12 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Calcipotriene and Betamethasone Dipropionate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIPOTRIENE .643 mg/g BETAMETHASONE DIPROPIONATE 50 ug/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 143NQ3779B Internal UNII lookup 826Y60901U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 388525 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 45802-816-01 Calcipotriene and Betamethasone Dipropionate 100 g in 1 TUBE OINTMENT 100 7 45802-816-01 Calcipotriene and Betamethasone Dipropionate 1 in 1 CARTON OINTMENT 1 7 45802-816-96 Calcipotriene and Betamethasone Dipropionate 60 g in 1 TUBE OINTMENT 60 7 45802-816-96 Calcipotriene and Betamethasone Dipropionate 1 in 1 CARTON OINTMENT 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-816 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE) OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD] 7 Current NDC, Legacy NDC, 4 package rows 20241222_ba55ff2b-9cfe-40dc-9dac-718cf141c171.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE Padagis Israel Pharmaceuticals Ltd ba55ff2b-9cfe-40dc-9dac-718cf141c171 2024-04-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200174 application number: ANDA200174 ndc (product): 45802-816 Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE Bryant Ranch Prepack d223e857-590e-48b9-b33e-1275537a508e 2024-02-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200174 application number: ANDA200174 Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE Bryant Ranch Prepack 174c5378-f2b9-4e9e-931a-4123137be62d 2023-12-07 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200174 application number: ANDA200174 Calcipotriene and Betamethasone Dipropionate CALCIPOTRIENE, BETAMETHASONE DIPROPIONATE Bryant Ranch Prepack d4b301c5-704a-406d-9d9c-74f006334f8a 2023-07-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200174 application number: ANDA200174
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 45802-816-01 45802081601 1 TUBE in 1 CARTON (45802-816-01) / 100 g in 1 TUBE 1 tube 2020-01-30 0000-00-00 No No Current 45802-816-96 45802081696 1 TUBE in 1 CARTON (45802-816-96) / 60 g in 1 TUBE 1 tube 2020-01-30 0000-00-00 No No Current