Home NDC 51672-1402 Calcipotriene and Betamethasone Dipropionate
Product NDC 51672-1402
11-digit product format 516721402
Labeler code 51672
Product ID 51672-1402_38e5b828-cecd-c95b-e063-6394a90ae2e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcipotriene and Betamethasone Dipropionate
Dosage form SUSPENSION
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA213269
Marketing category ANDA
Marketing start 2020-09-02
Substance BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE
Active strength 50; 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 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213269-001 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 2026-08-18 06:07:40 2026-07 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213269-001 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE 0.064%;0.005% SUSPENSION / TOPICAL AB 2020-09-02 a50c72e98297…
Observed Orange Book normalized TE history# 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 50 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 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 51672-1402-4 Calcipotriene and Betamethasone Dipropionate 60 g in 1 BOTTLE SUSPENSION 60 2 51672-1402-4 Calcipotriene and Betamethasone Dipropionate 1 in 1 CARTON SUSPENSION 1 2 51672-1402-8 Calcipotriene and Betamethasone Dipropionate 60 g in 1 BOTTLE SUSPENSION 60 2 51672-1402-8 Calcipotriene and Betamethasone Dipropionate 2 in 1 CARTON SUSPENSION 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1402 CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.] 1 Current NDC, Legacy NDC, 4 package rows 20200904_1d0ab2e6-1ab1-4d3e-ad55-7fa26446f191.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 · 1 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 51672-1402-4 51672140204 1 BOTTLE in 1 CARTON (51672-1402-4) / 60 g in 1 BOTTLE 1 bottle 2020-09-02 0000-00-00 No No Current 51672-1402-8 51672140208 2 BOTTLE in 1 CARTON (51672-1402-8) / 60 g in 1 BOTTLE 2 bottle 2020-09-02 0000-00-00 No No Current